Sr. Quality Engineer

Title: Sr. Quality Engineer

Location: Andover, MA

Contract Term: 12+ Months

Weekly 40.00 hours

1st Shift (8AM – 5PM )

The Quality Engineer will work as a member of a cross-functional project team engaged in new product development. The individual will work closely with R&D, Manufacturing, Medical Affairs and System Engineers. This individual will be responsible for ensuring that the product development project is executed and released meeting customer expectations, regulatory requirements, appropriate voluntary standards and BD policies and procedures. This role will also be engaged with the R&D Ops team to review and approve necessary engineering work orders related to product manufacturing.

Experience & Education:
• A BS degree in engineering. MS preferred.
• Five years minimum of Quality Engineering experience in the medical device industry, including a minimum of 3 years as a Quality Engineer supporting R&D

Knowledge, Skills And Abilities:
• Understanding of basic electrical/mechanical/software engineering principals.
• Proficiency in risk analysis techniques (e.g. fault tree, FMEA, Safety Assurance Case) and experience leading others through process mapping exercises and coaching others in problem solving.
• Excellent knowledge of design controls and 21CFR820, ISO 13485, ISO 14971, ISO 10993 and applicable medical device regulations.
• Class II medical device experience required, Class III preferred.
• Demonstrated ability to make critical decisions regarding product quality or quality system compliance. Ability to assess and articulate risk when evaluating a situation.
• Professional certifications (CQE, CQA, CRE) are desirable.
• Excellent communication, problem solving, organizational and interpersonal skills are required.
• Strong project management skills required
• Experience with software quality assurance principles preferred.