Quality Assurance Manager (m/f/d) New Product Introduction

Stryker Sports Medicine; Kiel; Hybrid; EUR 60.000 - 95.000; Vollzeit

Zusammenfassung

An established industry player seeks a dynamic NPI Quality Assurance Manager to lead a multi-site QA team dedicated to excellence in product introduction. This role involves strategic leadership, collaboration across global teams, and a focus on quality assurance in regulated environments. You will drive process improvements, advocate for risk management methodologies, and ensure compliance with industry standards while fostering a culture of accountability and high performance. Join a forward-thinking company that values diversity and offers flexible working arrangements, allowing you to balance on-site presence with remote work to maintain strong team relationships.

Leistungen

Flexible working hours

Partial home office option

Diversity and inclusion initiatives

Qualifikationen

• 6+ years in regulated manufacturing environments like Medical Devices or Pharmaceuticals.
• 2+ years leading teams across multiple sites.

Aufgaben

• Lead NPI strategy execution across multiple sites and ensure quality standards.
• Optimize product/process designs for quality and efficiency.

Kenntnisse

Leadership

Risk Management

Process Improvement

Quality Assurance

Statistical Process Control (SPC)

FMEA

Root Cause Analysis

Six Sigma

Fluency in English

Fluency in German

Ausbildung

Bachelor’s Degree in Engineering

Bachelor’s Degree in Science

Tools

Quality Tools

ISO 13485 Standards

Jobbeschreibung

As an NPI Quality Assurance Manager (m/f/d) at Stryker, you will lead a cross-functional, multi-site team of QA Engineers dedicated to upholding the highest quality standards during New Product Introduction (NPI). This dynamic role spans our key locations in Freiburg (Germany), Cork (Ireland), and Florida (USA), where you will provide technical and strategic leadership to drive process excellence, risk management, and product success.

You will be at the forefront of global collaboration, inspiring your team to proactively implement preventive measures and continuously improve product and process designs across regions.

What Will You Do:

• Partner with the NPI Director and the global QA NPI team to shape and execute the overarching NPI strategy across multiple sites.
• Lead the introduction of new products, processes, and technologies at the Freiburg, Cork, and Florida facilities, ensuring alignment with global quality standards and effective process risk management.
• Optimize both new and existing product/process designs in collaboration with cross-functional and cross-regional teams to drive quality, efficiency, and scalability.
• Provide strong technical direction and people leadership to a geographically distributed QA team, fostering a culture of continuous improvement, accountability, and high performance.
• Support new product introduction integration, maintaining compliance with industry standards and regulations.
• Advocate for the use of robust pFMEA methodologies to identify and mitigate process risks, ensuring the reliability and performance of new products.
• Strengthen relationships and facilitate effective communication with internal and external partners within Advanced Operations and GQO, ensuring successful product launches that meet regulatory requirements and team objectives.

What will you need:

• Bachelor’s Degree in Engineering, Science, or a related discipline.
• A minimum of 6 years’ experience in a regulated manufacturing environment, such as Medical Devices, Pharmaceuticals, Bio-Medical, or Automotive.
• 2+ years of experience leading and developing teams, ideally across multiple sites or regions.
• In-depth knowledge of regulatory requirements, standards, and regulations.
• Proficiency in quality tools such as Statistical Process Control (SPC), Process Control, Failure Mode and Effects Analysis (FMEA), Risk Management, Design Control, Root Cause Analysis, Poka-Yoke, and Six Sigma methodologies.
• Experience in design transfer and new product transfer processes.
• Fluency in English, with the ability to collaborate effectively with local and international teams.

Preferred:

• Proficiency in German, enhancing communication with diverse teams and stakeholders.
• Experience with ISO 13485 standards, demonstrating a strong understanding of quality management systems specific to the medical device industry.

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:

Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site of 3 days a week at our location should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.

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