Senior Quality Engineer
Provide 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. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
- Work closely with operations and other business functions to ensure quality performance of products and processes.
- Mentor, provide oversight and approval of NC & CAPA activities.
- Will be a high level expert in problem solving.
- Will Initiate and lead in the development and improvement of the manufacturing processes for existing and new products.
- Oversee and lead investigations during concession management.
- Review and approval of change management activities, challenges change effectiveness and drives 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.
- Provides technical direction in optimization of inspection methods and sampling.
- High proficiency in statistical methods and application.
- Participate in and lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.
- Aids 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.
- Coach and mentor the quality team and others business function in quality topics and activities.
- Steps in proficiently for management in case of temporal absence.
- 4 years experience in Quality
- Previous experience in regulated environment
- Proficient in understanding of Med Device manufacturing processes.
- 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.
- Is diplomatic, tactful and leverages excellent interpersonal keys to help achieve outcomes.
- Excellent English (both oral and written)
- Polish good to have
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
More information is available at stryker.com