Quality Engineer (Medical Devices, Class III)

Job Title:

Quality Engineer II (or Senior Quality Engineer - title flexible)

Full-Time Permanent Position

On-Site

Company Info:

Commercial-stage, 30-person Class III Catheter/Implant medical device start-up. Funding Stage: Round B in place (multiple investors including 2 Major Strategics).

Recent US FDA Approval for their flagship device/system and will be ramping soon. Additional applications for the technology are in R&D phase.

Job Overview:

The QE will play a key role in building and maturing the quality assurance function within a growing, fast-paced organization. This position supports the development and manufacture of implantable devices and their delivery systems. The QE will collaborate cross-functionally to ensure design controls, risk management, and regulatory compliance for both new product introductions and sustaining quality projects.

Reports to: Director of Quality

Job Responsibilities:

• Support the continued development of the Quality Management System and ensure that it remains in compliance with ISO 13485 / MDSAP requirements
• Collaborate with R&D, Operations and Project Management in product development and sustaining quality engineering activities
• Contribute to the design development process by supporting design verification testing, participating in process validation and assisting with design transfer
• Assist with risk management activities including developing risk management plans and risk analysis documents (Hazard Analysis, FMEAs)
• Administer the nonconforming material process (NCR) by ensuring timely disposition of material and completion of associated corrective actions (CAPA)
• Manage the change control process including processing change orders and supporting implementation of updates
• Demonstrate flexibility and adaptability in a start-up environment, balancing multiple projects and shifting priorities
• Exhibit strong written and verbal communication skills

Minimum Qualifications:

• Bachelor’s or Master’s Degree (engineering discipline, preferred) or equivalent experience
• 3-5 years of experience in quality engineering within a regulated medical device environment
• MUST HAVE: Medical Device quality engineering experience
• Functional knowledge of medical device design control, risk management and process validation requirements

Abilities / Preferred Qualifications:

• Prior start-up or growth-stage medical device experience
• Able to hit the ground running and operate effectively with limited oversight
• High attention to detail
• Experience with design & development of implantable medical devices

No H1B Sponsorships or C2C candidates

Local Candidates strongly preferred

Recruiting Contact:

Jim Smith

Cambridge Recruiters

20 years recruiting for interventional medical device companies (R&D, Mfg, Quality)

www.cambridgerecruiters.com