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Quality Engineer (DHF Remediation, Combo Device)

Remote:

Full Remote

Contract:

Freelance

Experience:

Senior (5-10 years)

Work from:

New Jersey (USA), United States

Offer summary

Qualifications:

Senior level Quality Engineer specialist, Experience with pre-filled syringes, Knowledge of DHF remediation and documentation, Experience with Class II/III devices, Familiarity with ISO 13485 compliance.

Key responsabilities:

Act as primary QA contact for vendors
Authorize and approve DHF documentation
Maintain QA programs and procedures
Ensure compliance with regulations
Conduct investigations and risk assessments

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Responsibilities and Requirements:

Our client is looking for a senior level Quality Engineer specialist with significant DHF remediation knowledge.
The client has deliverables coming up and needs a consultant to help hit specific deadlines.
This role is a combo device position, the consultant is required to have experience with prefilled syringes, Class II/III devices, and sterilization.
There are 3 medical device products, one is already on the market, one will be approved, and they will be launching in Q4 and the last they are filing for shortly.
The consultant is required to act as the primary QA contact for medical device vendors (packaging and manufacturing), DHF remediation, author and approve DHF documentation, assist with maintaining the QA programs, policies, and procedures and ensure 21 CFR part 820, 210-11 and ISO 13485 compliance of commercial material.
The consultant will also be required to have experience with investigations with packaging/manufacturing, troubleshooting, gap assessment, and risk assessments.
The ideal candidate will have experience with combo devices, pre-filled syringes, DHF remediation and documentation.
Combo device, DHF remediation, pre-filled syringes, QA oversight.