What are the responsibilities and job description for the Senior Quality Assurance Manager position at Innovative Career Resources & Staffing?
Join a globally recognized healthcare innovator that’s redefining what’s possible in medical technology. As a Senior Quality Assurance Manager, you’ll take the lead in advancing world-class quality systems that directly shape the future of patient health and safety worldwide.
This is your opportunity to step into a high-impact leadership role where you’ll guide a talented Quality team, drive excellence across operations, and play a pivotal role in maintaining our reputation for precision, integrity, and innovation.
What You’ll Lead:
You’ll own and elevate our core Quality Systems, including the Quality Assurance and Technical Investigations Group (TIG). Your leadership will ensure every product meets the highest global standards — because every patient deserves nothing less.
Key Focus Areas:
- Final Product Release & Compliance Oversight
- CAPA Programs & Continuous Improvement
- QMS Document Control & Validations
- Internal & External Audits
- Complaints, Change Notifications & Non-Conformances
Your Mission & Responsibilities:
- Manage all aspects of Quality Systems to ensure compliance, efficiency, and continuous improvement.
- Serve as a key authority on GMP and ISO standards, providing leadership and direction to cross-functional teams.
- Direct and host FDA and Notified Body inspections, ensuring flawless audit outcomes.
- Identify and implement process, product, and quality system enhancements across global operations.
- Deliver training and mentorship on Quality System Regulations, ISO standards, and best practices.
- Build and empower your team through hiring, mentoring, and professional development.
- Track and analyze KPIs, lead effective CAPA strategies, and report measurable improvements to leadership.
What you Bring:
- Bachelor’s Degree (Science, Engineering, or related field).
- Minimum 1 year of Auditor experience preferred.
- Proven experience within a regulated medical device manufacturing environment.
- Deep understanding of U.S. and international medical device regulations: 21 CFR 820, 803, 804 (MDR), ISO 13485, ISO 14971, ISO 13408, EU MDR 2017/745 / MDD 93/42/EEC, and Canadian/Brazilian MDR.
- Formal training in quality tools (CQE, CQA, Six Sigma, Risk Assessment, FMEA, FTA, DOE, Statistical Techniques).
- Hands-on experience with process/equipment validation, method validations, and technical investigations.
Why You Will Love It Here:
At this company, you won’t just manage processes — you’ll shape the quality culture of a global leader committed to scientific excellence and patient well-being. You’ll have a seat at the table where innovation meets purpose, and where your voice, ideas, and leadership truly make an impact.