Overview
Senior Quality Assurance Engineer Jobs in Billerica, MA at Agile Search Inc.
Title: Senior Quality Assurance Engineer
Company: Agile Search Inc.
Location: Billerica, MA
Own the entire quality system. Not a slice of it.
Most Senior Quality Systems Engineers inherit a QMS someone else built and spend their days maintaining it. This one is different.
Our client is a growth-stage medical technology company that has recently entered a strategic partnership with a Top 10 global medtech. The QMS has to scale with what’s coming next, and we’re hiring the person who will own that.
You will own the QMS end to end, ISO 13485 and FDA QMSR; gap analysis, recommendations, implementations. You lead internal audits and CAPA investigations through to real root cause. You build the quality metrics and statistical methods that drive risk-based decisions. You own supplier qualification and audits, post-market surveillance and MDR reporting.
You’ll also do something you can’t do at a large company: shape the quality culture of a small, multidisciplinary team from the inside, and mentor engineering and operations along the way.
Who this is for:
5+ years in medical device quality systems, with a track record of building and evolving a QMS.
Deep in 21 CFR 820, ISO 13485:2016, and ISO 14971. Comfortable with statistical methods, sampling plans, and validation data.
Self-directed, organized, and energized by a fast-paced environment.
Nice to haves (big plus):
CQE, CMDA, or lead auditor certification
eQMS implementation (Greenlight Guru, MasterControl, ETQ)
510(k) or CE technical file experience
Prior startup or early-stage medical device background
IEC 62304 and 60601-1 proficiency
If you’ve been waiting for the role where your fingerprints are on the system, this is that role, please apply today and we will be in touch.
Know someone who fits? Please tag or share.
