Quality Assurance Manager (m/f/d) Medical Devices

Stryker; Deutschland; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading medical technology firm in Germany is seeking a Quality Assurance Manager to lead a dedicated team ensuring product safety and compliance. The ideal candidate will have extensive experience in quality assurance within a regulated industry, drive continuous improvement, and facilitate audits. This role supports a collaborative environment while contributing to crucial global quality strategies. Opportunities for permanent placement are available after initial contract.

Qualifikationen

• 7+ years of technical experience in quality assurance or a similar field.
• Proven experience in internal and external audits.
• Solid understanding of manufacturing processes in regulated industries.

Aufgaben

• Lead a Quality Assurance team to ensure product and process quality.
• Promote a culture of continuous improvement and patient safety.
• Ensure regulatory compliance and lead internal and external audits.
• Drive talent development and engagement within the team.

Kenntnisse

Leadership

Quality Assurance

Continuous Improvement

Regulatory Compliance

Collaboration

English

German

Ausbildung

Bachelor's or Master's degree in Engineering, Science, or a related field

Tools

Lean Tools

Jobbeschreibung

Work Flexibility: Onsite

As a Quality Assurance Manager (m/f/d) at Tuttlingen, you will lead a skilled Quality Assurance team dedicated to ensuring the safety, performance, and compliance of innovative surgical technologies. You'll drive quality excellence across operations, champion continuous improvement, and partner with cross-functional teams to deliver best-in-class products. This is your opportunity to shape quality strategy, elevate standards, and lead with impact at one of the world's top MedTech companies.

What you will do

• Lead a dedicated Quality Assurance team, providing guidance, coaching, and direction across operational and functional areas to ensure product and process quality.
• Promote a proactive, continuous improvement culture, supporting initiatives to enhance quality performance, efficiency, and patient safety.
• Ensure regulatory compliance by aligning with Stryker's global quality standards, and leading internal and external audits (e.g., FDA, notified bodies).
• Drive talent development and engagement by recruiting, mentoring, and developing team members while fostering a positive and inclusive work environment.
• Act as a strategic partner in cross-functional projects, ensuring quality input in decision-making processes and risk management activities.
• Ensure control and resolution of product/process deviations, manage NCRs/CAPAs effectively, and assess product and patient risk.
• Monitor site Quality KPIs, identify adverse trends, and take timely action to maintain or exceed performance targets.
• Support global quality strategies and contribute to the overall success of the Quality Operations function across the organization.

What you will need

Required:

• Bachelor's or Master's degree in Engineering, Science, or a related field.
• 2 years of experience people leadership experience is a plus, but not required.
• 7+ years of technical experience in quality assurance, manufacturing, production, or a similar field within a highly regulated industry (medical devices, pharma, aerospace, food & beverage).
• Proven experience leading or actively participating in internal and external audits (e.g., FDA, Notified Body, Corporate)
• Solid understanding of manufacturing processes in medical devices or other high-risk, regulated industries.
• Excellent English and German language skills, enabling seamless collaboration with global and local stakeholders.

Preferred:

• Expertise in key quality processes, including non-conformance management, continuous improvement, auditing practices, lean tools, and core quality assurance techniques such as PFMEA, risk analysis, and inspection planning.
• Familiarity with EU MDR, ISO 13485, FDA 21 CFR Part 820, and global quality standards is desirable.

Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.

Additional information

The position is initially limited to 18 months. Due to the large number of different positions and areas of responsibility, Stryker often offers the options of being taken on in a permanent position.

Please note that the internal job title may differ from the ad title.

Travel Percentage: 20%