Primary Talent Partners has a 6-month contract opening for a Sr Manufacturing Quality Engineer to join a multinational medical device manufacturing company for a hybrid position operating out of Danvers, MA.
 
 Pay: $55/hr - $60/hr
Contract: 6 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or provide visa sponsorship
Location: Danvers, MA (4 Days Onsite, 1 day remote (subject to change depending on project requirements)
Product Lines: Cardiovascular, Neurovascular, Peripheral Devices 

A Day in the Life
In this exciting role as a Senior Quality Engineer, you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices in the area of component manufacturing. This includes activities related to test method validation, process validation, inspection improvements, and process/quality change initiatives.
 
Responsibilities Include:

• Provide Quality Engineering support for commercial medical device products.
• Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
• Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements.
• Present technical data to groups within and outside the organization.
• Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.

 
Education Required:

• Bachelor’s Degree in Engineering, Science or technical field AND 4 years of work experience in Engineering and/or Quality OR
• Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality

 
Years’ Experience Required: 4 years
 
Top 3 technical  skills that are required for the role:

1. Medical Device Design & Development
2. Risk Management: dFMEA, pFMEA, Statistical analysis
3. Technical Writing: IQs, PQs, TMVs

 
Nice to Have: Preferred Qualifications

• Medical Device
• Master’s degree
• Manufacturing Experience
• Green Belt Six Sigma/DRM Training/Certification
• ASQ-CQE, CQA, CBA or equivalent certifications
• SAP QM or SPC Software Experience
• Effective verbal and written communication, analytical, influencing and interpersonal skills
• Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016
• Demonstrated working knowledge of process validation, statistical methods, risk management
  
  

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [email protected]

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