Quality Assurance (QA) Manager
Integra LifeSciences
Datum: vor 1 Woche
Stadt: Ratingen, Nordrhein-Westfalen
Vertragstyp: Ganztags
Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Integra LifeSciences is seeking a dynamic and experienced Quality Assurance (QA) Manager to lead our EMEA Service and Repair Quality Operations. As a critical member of our team, you will oversee the Quality Management System (QMS) for our medical device servicing and repair, ensuring compliance with ISO 13485, FDA regulations, and other relevant standards.
About Integra LifeSciences:
Integra LifeSciences is a global leader in regenerative medicine, neurosurgery, and acute surgical solutions, dedicated to improving the quality of life for patients worldwide. We are committed to innovation, quality, and patient safety.
About the Role:
In this pivotal role at Integra LifeSciences, you will be responsible for maintaining a high level of customer satisfaction and product safety while driving continuous improvement within our service and repair processes. You will lead a team of dedicated professionals and act as a Center of Excellence resource for our global service centers outside of the US.
Key Responsibilities:
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
Integra LifeSciences is seeking a dynamic and experienced Quality Assurance (QA) Manager to lead our EMEA Service and Repair Quality Operations. As a critical member of our team, you will oversee the Quality Management System (QMS) for our medical device servicing and repair, ensuring compliance with ISO 13485, FDA regulations, and other relevant standards.
About Integra LifeSciences:
Integra LifeSciences is a global leader in regenerative medicine, neurosurgery, and acute surgical solutions, dedicated to improving the quality of life for patients worldwide. We are committed to innovation, quality, and patient safety.
About the Role:
In this pivotal role at Integra LifeSciences, you will be responsible for maintaining a high level of customer satisfaction and product safety while driving continuous improvement within our service and repair processes. You will lead a team of dedicated professionals and act as a Center of Excellence resource for our global service centers outside of the US.
Key Responsibilities:
- QMS Oversight: Develop, implement, and maintain a robust QMS that meets regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820.
- Regulatory Compliance: Ensure all service and repair activities comply with relevant regulations, lead audits, and stay abreast of industry changes.
- Team Leadership: Lead, mentor, and develop the EMEA Service and Repair Quality Operations personnel, fostering a culture of quality and safety.
- Continuous Improvement: Analyze data, drive CAPA initiatives, and optimize service efficiency and product reliability.
- Customer Interaction: Address customer concerns, provide feedback, and ensure timely resolution of service-related issues.
- Documentation & Reporting: Maintain accurate records, prepare quality reports, and ensure compliance with documentation requirements.
- Risk Management: Assess and mitigate risks related to service and repair processes.
- Bachelor’s degree with 5+ years of Medical Device experience.
- Proven experience in medical device service and repair with a focus on quality management and regulatory compliance.
- Strong knowledge of ISO 13485, FDA regulations (21 CFR Part 820), and other applicable regulatory standards.
- Experience with CAPA, audit processes, and root cause analysis techniques.
- Strong leadership, communication, and interpersonal skills.
- Detail-oriented with a passion for improving quality and safety standards.
- Demonstrated ability to build engagement, develop teams, foster relationships, and deliver results.
- Certification in Quality (e.g., CQE, CQA, Six Sigma).
- Experience managing service and repair teams in the medical device industry.
- Familiarity with service management software and data analytics tools.
- Be part of a leading global medical technology company dedicated to improving patient lives.
- Lead a talented team and make a significant impact on our global service operations.
- Opportunity for professional growth and development.
- Work in a Center of excellence.
- Join a company with a strong commitment to ethical practices and a culture of innovation.