Quality Assurance Manager mfd New Product Introduction
Quality Assurance Manager mfd New Product Introduction
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Job Description
As an NPI Quality Assurance Manager (m/f/d)at Stryker you will lead a crossfunctional multisite 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 facilitiesensuring alignment with global quality standards and effective process risk management.
Optimize both new and existing product/process designs in collaboration with crossfunctional and crossregional 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:
Required:
Bachelors Degree in Engineering Science or a related discipline.
A minimum of 6 years experience in a regulated manufacturing environment such as Medical Devices Pharmaceuticals BioMedical or Automotive.
2 years of experience leading and developing teams ideally across multiple sites or regions.
Indepth 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 PokaYoke 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.
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Travel Percentage: 20Required Experience:
Manager
Employment Type
Full-Time
