What are the responsibilities and job description for the Senior Quality Systems Engineer position at Agile Search Inc.?
Senior Quality Systems Engineer / Lead
Why this is different:
Opportunity to build a company's quality management system for the next stage of growth, including added product capability, building for scale and distributing the product globally.
About Agile Search's client:
A growth-stage medical technology company recently engaged with strategic partner and positioned for expansion.
Agile Search is conducting interviews for a Senior Quality Systems Engineer to join a commercial stage company and help them build out their Quality Management System for the next growth chapter.
Role specifics:
Reporting to the organization's VP QA RA
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.
Own supplier qualification 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.
Full time, on-site hire in Billerica, MA
5 years in medical device quality systems, with experience building and/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 with examples
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 or you know someone who you think could be a good match please apply, share this post, or get in touch with us directly at info@agilesearchinc.com
Thank you!
Agile Search
Salary : $125,000 - $158,000