Senior Advanced Quality Engineer
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Job Location:
Monthly Salary:
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Flexibility: Hybrid or Onsite
This is a Hybrid 23 month contract with full Stryker benefits
What you will do:
- Develop quality assurance documentation to support product transfer activities and regulatory submissions.
- Support quality system maintenance for the design control process by identifying and correcting deficiencies in procedures and practices.
- Engage in the design development manufacturing and risk management activities for product transfer projects.
- Engage in design reviews by identifying risks associated with the product used and tracking how the design documentation and manufacturing process mitigate those issues throughout the development process.
- Support the definition of design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
- Complete final design verification and validation reports by providing concise conclusions with statistical validity and graphical support.
- Promote efficient testing practices.
- Support Advanced Operations in the development of manufacturing processes for new products.
- Utilize standard statistical analysis and problem-solving techniques to determine product acceptance limits establish process parameters resolve quality problems etc.
- Develop review and approve inspection plans routers and product drawings for new products.
- Support product design transfers to internal and/or external manufacturing facilities.
- Evaluate predicate products for relevant quality issues tthat may impact new product development projects.
- Analyze and define critical quality attributes for product and process through risk analysis techniques.
- Participate in collection of initial market feedback on new products and address early concerns.
- Lead risk management activities by developing risk management plans and reports conducting risk reviews verifying implementation and effectiveness of risk controls.
What you will need:
Bachelors Degree in Engineering or a related discipline
2 years experience in engineering
Required Experience:
Senior IC
Key Skills
- Quality Assurance
- Six Sigma
- Design Controls
- FDA Regulations
- ISO 9001
- Minitab
- Root cause Analysis
- ISO 13485
- Quality Systems
- Quality Management
- As9100
- Manufacturing
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
