Senior Quality Assurance Manager
4 tygodni temu
About the Job
We are seeking a highly skilled and experienced Quality Assurance Manager to join our team at Stryker Poland Manufacturing sp. z o.o. In this role, you will be responsible for providing quality leadership and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes.
Key Responsibilities
- Work closely with operations and business functions to ensure quality performance of product and processes.
- Mentor, provide oversight and approval of NC & CAPA, activist and high-level expert in problem-solving and root-causing activities.
- 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, challenge change effectiveness and drive strong review.
- Interpret KPI trends, take action as necessary, driving a continuous improvement process.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- Subject matter expert in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
- Proficiency in and provides technical direction in optimization of inspection methods and sampling.
- Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manage audit logistics and preparation.
- Aid in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
- Responsible for initiation, management and support of ship, product Holds, potential product escapes.
Requirements
- 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 preferred.
- Proficient in ISO 13485, GDP, GMP.
- Lean Six Sigma training a distinct advantage.
- Have a good understanding of engineering and quality practices & methods.
- Must be willing to work as part of a multi-site team, with some travel required.
- High-level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
- Highly developed problem-solving and strong analytical skills.
- Excellent English and Polish (both oral and written).
- Ability to be the voice of Quality when dealing cross-functionally, will take the lead discussions / meetings to ensure the correct outcome.
- Experience in project transfer and validation processes.
Language English
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