Senior Quality Engineer-Medical Devices

Our client is an industry leading Regulatory and Quality consulting company that has consistent year over year growth and is on a major upswing with Design Assurance hiring. They work with startups to fortune 500 device companies, providing a variety of client projects.

These are full-time, permanent hire, remote-based positions. This has been the regular business model for many years, with full integration into client teams to meet project deliverables.

Key highlights:
- Women-owned business, established for 10 years with owners actively involved.
- Expert team members with opportunities to work on new technologies, projects, and clients.
- High employee satisfaction, with over 30% of hires this year from Associate referrals.
- Minimal travel to client sites required.
- Unlimited time off and a focus on work/life balance.

The person filling this role will work with a CMO on devices.

Skillsets:
Must have design assurance/design control knowledge, DHF development experience (having built a DHF from scratch), familiarity with device products, risk management experience, V&V planning/reporting (including sampling), familiarity with submissions, sterilization, biocompatibility, paper-based DHF, and design transfer.

Responsibilities:
- Provide design assurance support to review/create a DHF for clients.
- Develop Design Control SOPs for products. Major deliverables include:
Design Inputs, uFMEA, dFMEA, Risk Management Plan, Hazards Analysis, Design Verification Plan, Design Verification Report (including IFU & Labeling verification), Traceability Matrix, Design and Development Plan.
- Mentor and guide client teams on industry standard practices for product development, particularly on the device side.
- Work within client SOPs while advising on QMS updates to standardize design control best practices including risk management.

Other:
- International client / Eastern Time zone preferred.
- ISO 13485:2016 and applicable regulatory requirements of US FDA and Europe MDR.

There will be multiple hires of DA professionals with 2-15 years of experience over the next few months, starting in Jan/Feb.

Contacts:
For further information, please contact:

Hiring Organization:

Employment Type: Full-time

Beginning of Employment: ASAP

Medical Device/Pharma

Job Location: Remote work from: USA;
New Jersey, USA; D.C., USA;
Pennsylvania, USA;