See the impact of your work - in the eyes of patients everywhere.As we scale across our group of companies, we're looking for a
Senior Quality Engineer who wants more than a QA checklist - someone who wants to build, improve, and lead quality systems that directly protect patient safety and product performance. This role reports directly to the Director of Quality Assurance.
If you're a hands-on problem solver who thrives at the intersection of engineering rigor and regulatory excellence, this is your next challenge.
Why This Role- Real ownership. You won't just review documents - you'll lead CAPA reviews, drive root cause investigations, and own quality outcomes across product development, validation, and manufacturing transfer.
- Visible impact. Partner with the Director, Quality Assurance to achieve site KPIs, present to management, and see your process improvements translate directly into our portfolio of products.
- Cross-functional influence. Partner with engineering, manufacturing, and leadership teams - and build the kind of influence skills that accelerate careers.
- A team that values expertise. You'll be the go-to SME for internal and third-party audits, trusted to represent quality with confidence and credibility.
What You'll Do- Lead and shape quality policies, procedures, and systems that meet ISO 13485, GMP, GDP, and 21 CFR 820 standards
- Drive root cause analysis, CAPA, and continuous improvement efforts across cross-functional teams
- Own validation protocols for software, equipment, processes, and test methods
- Apply statistical analysis, risk management, and FMEA practices to strengthen manufacturing operations
- Support new product development and manufacturing transfers with a quality-first lens
- Train and mentor colleagues on quality processes, elevating the team around you
- Represent Quality as a subject matter expert in audits and management reviews
What You Bring- B.S. in Engineering (or equivalent) with CQE certification preferred
- 5-7 years of Quality Engineering experience - medical device background strongly preferred
- Hands-on CAPA process experience, start to finish
- Working knowledge of GMP, GDP, ISO 13485, and 21 CFR 820
- Strong analytical and problem-solving skills, with the organizational chops to juggle multiple priorities
- A collaborative communicator who can influence across all levels of the organization
- Bonus points: Six Sigma, FMEA, SPC, or Validation Program experience
