Engineer Jobs in Massachusetts

Job Title: Sr Supplier Quality Engineer - 32288 Company: Boston Scientific Corporation Location: Natick, MA Description: Delivering on the promise of medical innovation begins at Boston Scientific By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.  As an experienced assessor, provides Assessment support for activities related to supplier selection and evaluation, supplier performance, and strategic procurement project support. This includes performing detailed assessments of practices at suppliers manufacturing plants and sites to ensure that policies and procedures comply with Boston Scientific Corporation (BSC) standards. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions. Consults with supplier’s management to establish and implement practices and procedures that comply with BSC Requirements. The person in this role may be asked to mentor and train less experienced assessors, as well as contribute to the development and improvement of Supplier Quality processes and procedures. 2) Key Responsibilities • Plans and conducts scheduled assessments of suppliers to assess compliance with Boston Scientific requirements. Includes assessment preparation meetings and scheduling in advance of site visit. Conducts and confirms follow-up actions on Supplier Quality System Assessments. • Assesses supplier capabilities through direct visits, technical discussions and Quality System Assessments. • Prepares detailed trip reports and Assessment Reports to document assessment findings and observations. • Communicates quality issues to suppliers as needed and provides assistance to develop corrective actions. • Reviews, understands, and implements updates related to BSC Policy changes. Includes incorporation of this information into corporate and divisional programs through document reviews, protocol reviews, validation reviews, and training programs. • Participates with Corporate and regional Supplier Quality organization on policy/procedure/ guideline development. Includes generation, review, and implementation of these documents. • Works with various Alliance partners to assess and address material quality issues. • Generates Quarterly Supplier Performance Reports. • Tracks and trends supplier performance, taking remedial action as needed. • Interfaces with the Procurement Commodity Specialists. • Maintains accuracy of SAP Vendor Assessment Report and Supplier Profile Reports. • Provides guidance to Purchasing and Engineers in applying supplier quality system requirements. • Contributes and participates in supplier performance reviews. • Trains suppliers, assessors, and other BSC personnel on QA specifications for suppliers. • Supports the development of Supplier Quality infrastructure by working with management on the development and enhancement of critical processes and procedures, as well as training and mentoring less experienced staff. • Support the day to day activities that take place at Quincy for activities related to Alliance partner products 3) Qualifications Bachelor’s degree in a technical engineering field plus a minimum of 7 years experience auditing in the quality or medical device field; or equivalent combination of education and/or experience is required. . Knowledge of statistical sampling required. Certification as a Six-Sigma Green Belt or Black Belt preferred. Must be able to read and interpret technical drawings. Effective written and oral communication skills required. Audit training to ISO 9001, ISO 113485 or other industry specific standard, or equivalent experience in auditing required.4) Working Conditions* The noise level in the work environment is usually moderate within an office environment although job performance will necessitate frequent exposure in a manufacturing environment. This job entails frequent travel, up to 40% (primarily domestic, but some international) 6) Competency Expectations LANGUAGE SKILLS (ENGLISH): Ability to read, analyze and interpret general business periodicals, professional journals, and technical procedures. Proven experience in writing technical reports, business correspondence and procedure manuals. Demonstrable ability to effectively present information and respond to questions from groups of managers, vendors, customers and the general public. MATHEMATICAL SKILLS: Demonstrates proficiency to work with mathematical concepts such as probability and statistical inferences and fundamentals of plane and solid geometry. concepts such as fractions, percentages, ratios and proportions to practical situations. REASONING ABILITY: Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Capable of making decisions impacting product quality, corrective actions, etc. Root cause analyses of problems encountered during the development of a product or in production are required. OTHER SKILLS AND ABILITIES:  computer literacy with the Microsoft Office Suite§Proven

Job Title: Quality Engineer Company: Location: Worcester, MA Description: SMC began its commitment to plastic injection molding, engineering and manufacturing nearly 2 decades ago. Today SMC is a renowned business leader across the globe specializing in contract manufacturing of medical devices based on a platform of injection molding. We pride ourselves in creating a business to top notch customer service while maintaining a family oriented organization. Position Scope and Purpose: Responsible for all areas of Quality Engineering and working directly with the engineering, tooling and manufacturing functions making sure adequate systems and inspection methods and tools are used throughout the plants for molding or assembling products. Understanding customer requirements and implementing action plans, purchasing equipment or tools necessary to perform tasks. Ensure proper controls, operator instructions and quality tools used to verify customer?s products at all phases within our process. Duties and Responsibilities: ? Review daily rejects or complaints and implement or discuss action plans ? Disposition In-Process rejected product from previous day (MRB), if required ? Make appropriate changes in documentation to prevent recurrence ? Make appropriate changes to fixtures or inspection methods and tools ? Create/Modify and Maintain History Cards/ Control Plans ? Make decisions regarding quality related questions as appropriate ? Contact customers via verbal/written communication as appropriate ? Create/Maintain FMEA?s, Control Plans, Validation Plans, IQ/OQ/PQ protocol?s, PPAP?s as appropriate ? Participate in design reviews as required ? Visit customers with regards to customer complaint resolutions ? Participate in plant/department meetings and tours as required ? Review PPAP, FAIR?s, Validation Data, and M&P studies before sending to customer ? Work with Engineering, MFG and Tooling to develop corrective actions and continuous improvement activities. ? Report any unsafe conditions to Manager or Safety committee member ? Maintain cleanliness of work areas and quality measuring equipment ? Observe all health and safety requirements ? Perform any and all other duties assigned Desired Qualifications: ? 2-4 year college degree or Quality related experience. ? Minimum of 5 years experience in a Quality Engineering ? Must be able to read and understand 2D detailed part/article drawings ? Must understand the use all Quality related inspection equipment ? Must have excellent problem solving and mistake proofing skills ? Must have computer skills and familiarity with Word and Excel programs ? Must have knowledge of SPC and ISO 9001 & 13485 system requirements ? Ability to work well with others and independently ? Excellent written, verbal, and presentation skills ? Ability to lift up to 30 lbs.

Job Title: Supplier Quality Lead Engineer-Whatman Company: GE Technology Infrastructure Location: Westborough, MA Description: Business GE Technology Infrastructure Business Segment Technology Infrastructure - Healthcare About Us GE Healthcare provides transformational medical technologies that are shaping a new age of patient care. GE Healthcare's expertise in medical imaging and information technologies, medical diagnostics, patient monitoring and life support systems, disease research, drug discovery, and biopharmaceutical manufacturing technologies is helping physicians detect disease earlier and to tailor personalized treatments for patients. GE Healthcare offers a broad range of products and services that are improving productivity in healthcare and enhancing patient care by enabling healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. Headquartered in the United Kingdom, GE Healthcare is an $18 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 48,000 people committed to serving healthcare professionals and their patients in more than 100 countries. Role Summary/Purpose The Supplier Quality Engineer is responsible for driving exceptional product quality for the patient, customer value beyond expectations, regulatory assurance and optimized Cost of Quality for GE Healthcare (GEHC). This is a key technical leadership position, affecting part quality for both installed base and New Product Introductions parts. Essential Responsibilities 1. Improve supplier quality performance for assigned suppliers via Quality Plan implementation. 2. Approve supplier selection through robust qualification processes. 3. Assure supplier compliance to GEHC Quality Management System (QMS) and regulatory requirements through supplier monitoring process. 4. Develop positive relationships and work closely with Global Sourcing Leaders and Modality Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers. 5. Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize Costs of Quality, specifically Failed on Arrival/Install (FOA/FOI) issues, Field Failures and Factory defects. 6. Assure Corrective and Preventive Action (CAPA) plans are developed and executed at assigned suppliers in compliance with CAPA process. 7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance. Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines. 3. Identify and report any quality or compliance concerns and take immediate corrective action as required. 4. Knowledge and understanding of GEHC Purchasing Controls Procedure and associated Work Instructions and operates within them to ensure that all purchased product and services conform to specified requirements. 5. Ensure a compliant and qualified supply base by conducting supplier evaluations. Qualifications/Requirements 1. Bachelors Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience).2. Minimum 3 years experience in manufacturing, engineering design, quality assurance or regulatory assurance.3. Proficiency with Microsoft Excel Spreadsheet development and analysis.4. Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross functionally and globally).5. Must submit application through gecareers.com (or COS if internal applicant) to be considered.6. Must be willing to take a drug test and submit to a background investigation as part of the selection process.7. Must be willing to work in Westborough, MA Additional Eligibility Qualifications GE will only employ those who are legally authorized to work. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen. Desired Characteristics 1. Minimum 3 years experience in manufacturing, design, quality assurance or regulatory assurance. ASQ Certified Quality Engineer. 2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.4. Demonstrated collaboration, negotiation & conflict resolution skills.5. Excellent oral communication & report, business correspondence & procedure-writing skills.6. GEHC experience. ........................................................................................................................................... We offer a competitive salary, outstanding benefits package and the professional advantages of an environment that supports your development and recognizes your achievements. We are an Equal Opportunity Employer...........................................................................................................................................

Job Title: Supplier Quality Assurance Engineer Company: Acme Packet Location: Burlington, MA Description: Supplier Quality Assurance EngineerTracking Code5300-1Job DescriptionResponsibilities:* Participate in the supplier quality sourcing strategy, to help assure cost effective, on time, high quality product delivery. Engage in the supplier selection, evaluation and approval process.* Drive suppliers to identify appropriate quality assurance systems that will ensure receipt of defect free systems/components/materials. Drive suppliers to establish quality assurance systems based in prevention, utilizing capability studies, design and process FMEA, SPC, DOE, process validations, gage R&R, and other quality tools, as appropriate.* Develop supplier scorecards; analyze supplier performance data, report on and monitor supplier performance and drive continuous improvement efforts on suppliers. Participate in the cost savings opportunities.* Work with Engineering, Manufacturing, and Quality, as needed, in developing and defining inspection/product conformance criteria for workmanship, assembly and cosmetic defects and communicating that criteria and expectations to suppliers.* Champion the MRB process for supplier caused defects.  Communicate identified issues, and drive corrective action and preventive actions by the suppliers.  Monitor failure trends and manage FA activity on any electronics subassemblies and or components.* Manage supplier corrective action program that will drive issues through root cause resolution in a timely fashion.* Play a pivotal role supporting EMS supplier efforts in direct order fulfillment to ensure highest product quality level is achieved in a timely and cost effective manner.* Develop supplier audit schedules, conduct on site audits to improve overall performance of suppliers. Follow through for effective closure on any findings and/or opportunities for improvements.  * Develop and monitor effective audit sampling plans tailored to specific products and materials and make modifications, as needed.* Support the new product development process, as needed. Participate in the first article approval to ensure that the product quality conforms to its specification. Monitor effective closure of DFM report findings. Work with Engineering closely to ensure that the customized product specification is clearly understood by the suppliers and conformed to and its functionality requirements are fully tested before it is manufacturing ready.Experience/Qualifications:* BS degree or equivalent in a technical discipline. 5+ year supplier quality or supply chain management and/or engineering that included driving supplier performance improvements and/or meeting and organization's needs.  * Experience in an electronics environment; working knowledge of electrical components and systems.* In depth knowledge of Quality principles is essential, ASQ QE, Green/Black belt certification is preferred. Lean Manufacturing experience is a plus.* Knowledge of quality improvement tools (i.e. SPC, sampling plans, FMEA, Process capability, DOE, Gage R&R) desirable. * Familiarity with IPC-610, IPC-6011 and IPC-6012. Good understanding of PCB manufacturing processes, soldering, electronics assembly practices and workmanship acceptance criterion.* Experienced as an auditor, working knowledge of ISO standards. Knowledge of sampling methods, such as MIL-STD-105E.* Excellent project management, communication skills, ability to work independently in a multi tasking environment with a sense of urgency. Working knowledge of MS Office applications.Job LocationBurlington, MA, US.Position TypeFull-Time/Regular

Job Title: Supplier Quality Engineer (QUA100C6) Company: BD Biosciences Discovery Labwa Location: Billerica, MA Description: Job Summary: Working out of our Billerica, MA location, this individual contributor will assume the role of Quality Representative for OEM manufactured products and product distribution quality.  The successful individual will participate in divisional and corporate teams including, but not limited to, supplier quality, supplier selection and management, product distribution, product transfers, CAPA, and continuous improvement.  Specific responsibilities include: supplier audits, implementation of operational strategies, implementation of supplier quality systems, authoring of supplier quality procedures, facilitating risk analysis (FMEA, etc.), root cause problem solving, coordinating supplier validations, and launching new OEM products.  Additionally, this individual will work on complex problems where analysis of situations or data requires an evaluation of intangible and variable factors that directly impact the business.  The successful candidate will be subject matter expert, leader, and teacher of supplier quality, auditing, problem solving, and root cause corrective action (i.e. DOE, six sigma tools, failure analysis, etc.).                    Knowledge & Skills, Education & Experience:Requires BA/BS degree in an engineering or scientific related field plus 5-10 years industry experience or equivalent mix of education and experience.Must have Six Sigma Green Belt Certification (Black Belt preferred); and/or ASQ Certified Quality Engineer.Must have Lead Auditor experience and/or ASQ Certified Quality Auditor.Must have proven experience with implementation and achievement of business goals through cross-functional teams and staff. Working knowledge of U.S. and international regulations (i.e. QSR, ISO, CE-IVD, engineering standards, etc..). Proven analytical, quantitative, problem solving skills with expertise in root cause identification and implementation of corrective action. Effective knowledge and application of quality tools (i.e. Six Sigma, FMEA, Risk Analysis, Lean, Statistics, DOE, etc..).Ability to effectively manage travel to suppliers and other BD facilities (approximately 25%). About the Company:BD is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 28,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.  BD is an Equal Opportunity/Affirmative Action Employer. To apply:Visit our website:  http://www.bd.com/us/careers/jobs.asp Keyword:  QUA100C6