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

Stryker Group; Tuttlingen; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading MedTech company in Tuttlingen is seeking an experienced Quality Assurance Manager. The role involves leading a quality assurance team, ensuring compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have significant experience in quality assurance and manufacturing processes, as well as strong leadership skills. Proficiency in both English and German is required for effective collaboration.

Qualifikationen

• 7+ years of technical experience in quality assurance, manufacturing, or similar field.
• Proven experience in leading or participating in audits.
• Solid understanding of manufacturing processes in medical devices.

Aufgaben

• Lead a dedicated Quality Assurance team.
• Promote a proactive, continuous improvement culture.
• Ensure regulatory compliance with global quality standards.

Kenntnisse

Leadership

Quality Assurance Expertise

Regulatory Knowledge

Continuous Improvement

Auditing Skills

Bilingual (English and German)

Ausbildung

Bachelor’s or Master’s degree in Engineering, Science, or related field

Jobbeschreibung

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

1. Lead a dedicated Quality Assurance team, providing guidance, coaching, and direction across operational and functional areas to ensure product and process quality.

2. Promote a proactive, continuous improvement culture, supporting initiatives to enhance quality performance, efficiency, and patient safety.

3. Ensure regulatory compliance by aligning with Stryker's global quality standards, and leading internal and external audits (e.g., FDA, notified bodies).

4. Drive talent development and engagement by recruiting, mentoring, and developing team members while fostering a positive and inclusive work environment.

5. Act as a strategic partner in cross-functional projects, ensuring quality input in decision-making processes and risk management activities.

6. Ensure control and resolution of product/process deviations, manage NCRs/CAPAs effectively, and assess product and patient risk.

7. Monitor site Quality KPIs, identify adverse trends, and take timely action to maintain or exceed performance targets.

8. 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 in people leadership 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.