Quality Assurance Manager

GC America is a global leader in dental care and oral health. With more than 100 years of history, presence in over 100 countries, and a team of over 3,500 people worldwide, we are proud to support dental professionals with innovative, high-quality products that truly make a difference for patients. Our teams across Europe, North America, and Asia work together to develop and manufacture precision components for the dental industry, always focused on quality, innovation, and improving lives.

At GC, we believe in working with care and purpose. Our company philosophy, SEMUI, is all about thinking from the standpoint of others, whether that’s our customers, our teams, or the people who use our products every day. It’s this mindset that helps us drive innovation, respect each other, and create real value for the future of oral health. If you’re looking to join a successful, global company with real career opportunities, we’d love to meet you.

GC America is seeking an experienced Quality Control & GMP Compliance Manager to lead quality control operations and ensure compliance with FDA regulations, cGMP requirements, and ISO standards within our dental materials manufacturing environment.

• Lead Quality Control laboratory operations, including raw material, in-process, and finished product testing.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), cGMP requirements, and ISO 13485 standards.
• Serve as the primary contact for FDA inspections, audits, and regulatory inquiries.
• Oversee CAPA, deviations, non-conformances, complaint investigations, and supplier quality programs.
• Support process validation, change control, and continuous quality improvement initiatives.
• Develop and promote a culture of quality, compliance, and operational excellence.

• Bachelor's degree in Chemistry, Biology, Engineering, Materials Science, or a related field.
• 5+ years of experience in Quality Assurance, Quality Control, or GMP Compliance within an FDA-regulated environment.
• Experience supporting FDA inspections, audit readiness, and quality management systems.
• Medical device, dental materials, or regulated manufacturing experience preferred.
• Strong knowledge of FDA regulations, cGMP, CAPA, root cause analysis, and process validation.

At GC, you will be part of a growing, innovative company with a global footprint. We offer a collaborative, international work environment where your expertise has a direct impact.

• 401(k) through Fidelity and company matching 10%
• Dental insurance with Delta Dental PPO
• Employee Assistance Program
• Health Savings Account
• Company Paid Life Insurance two times the annual salary
• Paid time off, including an extra paid week off the week between Christmas and New Year
• Vision insurance Eye Med

We look forward to receiving your application. Please note that due to the high volume of applications, only shortlisted candidates will be contacted. Thank you for considering GC America as your next career step.

The total compensation range for this position is $130,000- $160,000. GC America values our Total Rewards, and offers a competitive and comprehensive Benefits Package including, but not limited to, Medical, Dental, Vision, Family Forming benefits, Life & Disability Insurance, and Paid Time Off. GC America reserves the right to amend, change, alter, and revise pay ranges and benefits offerings at any time.

All applicants acknowledge that by applying to this position you understand that this specific pay range is contingent upon meeting the qualifications and requirements of the role. It is at the Company's discretion to determine what pay is provided to a candidate within the range associated with the role.