What are the responsibilities and job description for the Principal Quality Systems Engineer position at Agile Search Inc.?
Principal Quality Systems Engineer
Agile Search is conducting interviews for a Principal Quality Systems Engineer to join a commercial stage company and help them build out their Quality Management System for their next stage of growth.
Role specifics:
Assume ownership of the QMS end to end, ISO 13485 and FDA QMSR; perform gap analysis for the company's growth, contribute directly to building the system, leading meetings as required, conducting risk management, making recommendations, voice of quality leading implementations.
Lead internal audits and CAPA through to root cause, build the quality metrics and statistical methods that drive risk-based decisions.
Contribute across supplier qualifications and audits, post-market surveillance and MDR reporting.
Contribute to directly shaping the quality culture for this expanding, multidisciplinary team.
Please apply / reach out directly if you meet the below qualifications and would like to schedule a confidential interview.
This is a full time, on-site hire located in Billerica, MA.
5 years of deep experience with medical device quality systems, ideally with some of that experience with a growing small company or building or evolving a QMS.
Proficiency in the application of 21 CFR 820, ISO 13485, and ISO 14971.
Comfortable with statistical methods, sampling plans, and validation data.
Energized by a fast-paced, growth stage company environment.
Big plusses for this role:
eQMS implementation experience
Prior startup or early-stage medical device growth experience
Proficiency in electromechanical medtech
Proficiency with Software Quality Systems
Expertise applying IEC 62304 and 60601-1
510(k) or CE technical file experience
CQE, CMDA, or lead auditor certification
If this is you, apply now.
Know someone who could be a good match? Share this listing with them, or get in touch directly at john@agilesearchinc.com