Sr. Quality Systems Manager

Agile is looking for a  Sr. Quality Systems Manager in Burlington MA

Job Summary

As Quality Systems Specialist, he/she will perform tasks that will uphold and improve the product quality of medical devices manufactured and meet regulatory requirement to stay in compliance.

What you will be doing:

1. Executes day-to-day activities based on quality objectives (goals) complementary to corporate policies and goals of building high quality medical devices.
2. Manages the CAPA program with the assignment of new CAPAs, following-up with owners on open CAPAs, and completion of effectiveness checks
3. Owns and implements Quality System Corrective and Preventative Actions
4. QMS SOP authoring and improvement
5. Updating QMS based on new quality standards
6. Updates the quality system based on non-conformities found during internal and external audits
7. Improving the QMS processes and infrastructure using Master Control QMS software
8. Supporting external audits from regulatory agencies
9. Build a strong understanding of ISO13485

What we require from you:

• Bachelor’s degree (B.A., B.S.) from four-year college or university; and a minimum of 7 years of experience in medical device industry

We are Committed to Your Success

We offer a competitive package, dynamic work environment, collaborative team, and space to learn, grow and thrive. Qualified applicants will receive consideration regarding race, color, religion, sex, national origin, age, sexual orientation, gender identity, gender expression, veteran status, or disabilities.

If you are a hardworking, driven professional looking for your next team. We are committed to employing a diverse workforce,  let’s start a conversation. Apply today!

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