Senior Quality Assurance Engineer

2 weeks ago


Flanders, New Jersey, United States Ampcus Full time
Job Description

Ampcus is seeking an experienced Senior Quality Assurance Engineer to lead Process Validation activities in manufacturing. This role will work with cross-functional teams to determine validation activities required for projects as well as engineering and process changes.

Key Responsibilities
  • Support validation process through protocol drafting, approval, and execution, and provide validation training and guidance.
  • Chair the Process Change Review Board and participate in Validation Review Board meetings.
  • Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead.
  • Lead improvement initiatives for Quality Assurance.
  • Independently perform a full range of standard work.
Required Skills and Qualifications
  • In-depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports.
  • Proven ability to lead projects.
  • In-depth knowledge of requirements related to ISO 13485 and FDA QSR.
  • Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control.
  • Experience with product transfers and new product development projects.
  • Experience with problem-solving techniques and CAPA investigations.
  • Strong organizational skills and ability to prioritize.
Estimated Salary

$90,000 - $120,000 per year, based on industry standards and location.

About Ampcus

Ampcus is a leading provider of quality assurance services in the medical device industry. We are committed to delivering exceptional results and fostering a culture of excellence.


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