Quality Control Manager

Conshohocken, Pennsylvania

Purpose:

Do you thrive on driving excellence and ensuring the highest standards of quality in a fast-paced, highly regulated environment? As a Quality Control Manager, you’ll play a pivotal role in shaping the safety and reliability of life-changing medical devices and HCT/Ps. This is your opportunity to lead a dynamic team and make a real impact in a company dedicated to improving lives.

Key Responsibilities:

In this role, you’ll be at the forefront of quality assurance, leading initiatives that ensure our products and processes meet rigorous regulatory and industry standards. Your day-to-day responsibilities will include:

• Staying ahead of the curve by maintaining expert knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB, and other relevant regulations.
• Developing and optimizing procedures and controlled documents to ensure compliance with FDA and industry standards.
• Leading investigations into deviations, nonconformances, complaints, and CAPAs, ensuring root cause analysis and timely corrective actions are implemented effectively.
• Managing and overseeing quality control processes, including incoming inspections, environmental monitoring, and equipment cleaning records.
• Partnering on new projects and product development, ensuring quality is a priority from concept to execution.
• Supporting validation and qualification protocols that meet regulatory expectations and exceed industry best practices.
• Preparing for and participating in internal, client, and regulatory audits, ensuring compliance across all operations.
• Leading and inspiring a team of quality professionals, driving performance, and fostering growth through coaching and training.
• Recruiting, hiring, and developing top talent to build a world-class quality team.

What You’ll Bring:

• A passion for leadership and a proven track record in quality management, particularly in FDA-regulated environments.
• Unparalleled attention to detail, strong organizational skills, and a proactive approach to problem-solving.
• Exceptional communication skills to articulate complex processes and collaborate across teams.
• The ability to juggle multiple priorities without losing focus on what matters most—ensuring excellence in every product and process.

Education & Experience:

• A bachelor’s degree in Biological Science or a related field is required.
• At least 5 years of experience in quality roles within FDA-regulated industries (HCT/Ps, medical devices, or similar), with demonstrated success in management and leadership.