Principal Quality Engineer

  • Location
    Mansfield, Massachusetts
  • Job type
  • Category
    Engineering - Quality

Position Details

Position: Principal Quality Engineer

Location: Mansfield, MA (02048)

Duration: 12 Months (Temp to Perm)

Compensation: Up To $108,000

Salary Upon Conversion: $110k - $120k (Up to 15% Bonus Possible)

Travel: 25% (Possibility of International Travel)

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Job Function
This position is for a Principal Quality Engineer with hands on experience and proven success supporting new product development activities. This position offers opportunity to lead DQE initiatives and provides exposure to multiple projects. The candidate will lead and support NPD projects to ensure desired design and product performance levels are met in compliance with all applicable regulatory requirements and Covidien Policies and Procedures.

Candidates should have DQE experience for a Principle level position. In particular, the candidate should have hands on experience directly supporting NPD initiatives and exposure to software embedded electro-mechanical devices. The candidate should be versed in ISO 14971, IEC 60601, ISO 62304, and ISO 62366. Experience with Reliability principles and Home Use Devices is a plus.

Job Summary
• Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards.
• Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.
• Lead all risk management activities, ensure procedures and files are maintained to State of the Art, and ensure all applicable staff are sufficiently knowledgeable.
• Contribute to the streamlining and continuous improvement of the product development process to ensure robust and efficient development and launch of new and innovative healthcare products.
• Provide guidance for the application of internal development procedures, including Design Control, to the product development teams, within the framework of regulatory requirements.
• Provide guidance and interpretation for industry related regulations within the framework of Covidien product and sustaining development processes.
• Interact and form constructive working relationships with all levels of leadership within Quality, Procurement, Marketing, R&D, and Operations.
• Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.

Position Requirements:
• B.S. in Engineering or associated scientific discipline.
• Minimum 5 years of experience with medical devices in a Quality or R&D Engineering position.
• Proficient with Minitab
• Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
• Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
• Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
• Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.

Preferred Skills/Qualifications:
• DFSS or DMAIC Black Belt Certified
• Certified Quality Engineer (CQE)
• Certified Quality Auditor (CQA)

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How to Apply
Click on “Apply Now” to be considered for this position or any other opportunities with Adecco.

If you have any questions surrounding the application process, please feel free to contact Elena Jarvis at

Why Adecco? Because Adecco provides one of the most COMPREHENSIVE BENEFITS package in the industry to contract workers. Just take a look at a few of the benefits available to you as a contractor:
Medical Coverage – access to an affordable and comprehensive group medical coverage plan
401(k) – Adecco offers all temporary employees the ability to participate in a 401(k) savings program
Pay Options/Direct Deposit – we make it as easy as possible for you to get paid
Paid Holidays – selected paid holiday, based on accrued hour requirements
State-of-the-artCareerCenter– training and resources available for all employees
Highly trained and professional staff – Our team cares about you and your career!

In addition to the position above, please feel free to look at all Adecco opportunities by visiting

Adecco is an equal opportunity employer. The Adecco Group is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions.

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Reference number US_EN_2_022862_397841