Overview
Quality Assurance Manager – Medical Device – Job ID: 254292 Jobs in Greater Pittsburgh Region at Medix™
Title: Quality Assurance Manager – Medical Device – Job ID: 254292
Company: Medix™
Location: Greater Pittsburgh Region
Manager of Quality Assurance (Medical Device)
Location: Pittsburgh, PA (Lower Allegheny Valley)
Compensation: $120,000 – $145,000 + bonus opportunity
Are you an experienced Quality Assurance leader looking to make a direct impact on life-saving medical technologies? Medix is partnering with a fast-growing, global medical device leader to find a Manager of Quality Assurance for a direct-hire, on-site opportunity!
In this role, you will lead a dedicated team of 20+ quality assurance inspectors and quality engineers within a sophisticated Class 3 PMA manufacturing environment. If you thrive in a culture of innovation and want your work to genuinely improve patient outcomes worldwide, we want to hear from you!
Key Responsibilities:
- Team Leadership: Direct, guide, and manage a high-performing department of 20+ QA inspectors and quality engineers.
- Compliance & Audits: Oversee the CAPA program, nonconforming material processes, and lead both internal and external quality audits.
- Operational Oversight: Manage inspection and product release programs for incoming materials, in-process goods, and finished products.
- Data & Strategy: Perform trend analysis on quality metrics, maintain written inspection instructions, and present key reports to senior management.
- Resource Optimization: Ensure sufficient staffing and resource allocation to seamlessly achieve both business goals and strict compliance standards.
What You Bring to the Table:
- Education: Bachelor’s Degree required.
- Leadership Experience: A minimum of 5 years of proven Management/Leadership experience.
- Industry Expertise: Strong background in a medical device manufacturing environment (4+ years as a QA engineer or in a technical discipline preferred).
- Regulatory Mastery: In-depth, applied knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
- Problem-Solving Skills: Advanced problem-solving abilities with the strategy-driven mindset needed to optimize risk, safety, and productivity.
- Preferred Certifications: ASQ Certified CQE, CRE, or CQM, and Lean Six Sigma training are highly preferred.
Why This Opportunity?
This is your chance to step into a pivotal leadership role where your strategic vision directly safeguards product quality and compliance. You will be joining an entrepreneurial, self-motivated culture that operates in over 140 countries, dedicated to making a meaningful difference in people's lives every single day.
How to Apply
Ready to take the next step in your QA leadership career? Apply directly to this post for immediate consideration!
