Senior Quality Assurance Manager
1 dzień temu
At Stryker Poland Manufacturing sp. z o.o., we are seeking a highly skilled Senior Quality Engineer to join our team. As a key member of our quality operations team, you will be responsible for providing quality leadership and direction in quality assurance, control, and preventative activities within operations and other business functions.
Key Responsibilities:- Work closely with operations and business functions to ensure quality performance of products and processes.
- Mentor and provide technical direction across multiple areas of expertise.
- Initiate and lead in the development and improvement of manufacturing processes for existing and new products.
- Oversight and lead investigations during concession management.
- Review and approval of change management activities.
- Interpret KPI trends and drive a continuous improvement process.
- Advocate for Human Factor practices and proficient in the science of Human Factor identification and mitigation.
- Subject matter expert in risk management practices and tools.
- Participate in and may lead internal and external audits.
- Aid in the development of validation strategies.
- Support manufacturing transfers to other plants/facilities.
- Bachelor of Science, Engineering, or related subject and 4 years of work experience in a quality discipline.
- Proficient in understanding of Med Device manufacturing processes.
- Proficient in ISO 13485, GDP, GMP.
- Lean Six Sigma training a distinct advantage.
- High level knowledge/experience of Risk Based and statistical techniques.
- Excellent English and Polish (both oral and written).
- Ability to be the voice of Quality when dealing cross functionally.
We offer a dynamic and challenging work environment with opportunities for growth and development. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application.
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