Senior Quality Engineer
Senior Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Stryker is hiring a Senior Quality Engineer to support our Global Quality Operations team working within our Trauma & Extremities business in Arlington TN! As a Senior Quality Engineer you will provide quality leadership and direction in quality assurance control and preventative activities within operations with a focus on preventative measures and continuous improvement of products and processes. You will advocate and lead the of initiatives & projects to enhance quality performance within the business.
What you will do:
- Provide engineering expertise in quality assurance control and prevention driving continuous improvement in internal products and processes.
- Address and resolve supplier quality issues affecting daily operations ensuring minimal disruption and compliance with standards.
- Advocate for and lead projects that enhance quality performance for internal processes and customer satisfaction.
- Ensure alignment with industry regulations and standards while maintaining highquality manufacturing practices.
- Work with Divisional QA suppliers and crossfunctional teams to resolve top quality issues managing internal and supplier nonconformances and CAPAs.
- Maintain KPIs analyze trends and implement corrective actions to monitor and improve process and product quality.
- Engage in optimizing internal manufacturing processes including process and equipment validation/qualification and MSA.
- Support analysis of manufacturingrelated complaints and product field actions while driving initiatives to reduce defects and enhance overall site QA activities.
What you will need:
Basic Qualifications:
- Bachelors degree in a science or engineering related discipline.
- Minimum of 2 years of experience as an Engineer in the areas of quality manufacturing or operations within a highly regulated industry in following cGMP and GDP regulations.
Preferred Qualifications:
- Understanding of US and International Medical Device Regulations with familiarity in ISO 13485 with experience in a medical device pharmaceutical or biopharmaceutical industry.
- Experience in interacting with regulatory agencies (FDA MoH TUV etc. desired.
- Strong knowledge of Quality Concepts (e.g. Risk Management CAPA Audits Statistics).
- Six Sigma Green or Black belt preferred.
Required Experience:
Senior IC
Employment Type
Full-Time
