Senior Advanced Quality Engineer
Stryker Employment Company, LLC
🇮🇪 Ireland
On-site
Senior
1 month ago
- Risk Management
- Black Belt
- FMEA
- GD&T
- CAD
- CAPA
1 month ago
- Develop quality assurance documentation to support new product development process 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 new product development 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 for new product development teams by developing risk management plans and reports, conducting risk reviews, verifying implementation and effectiveness of risk controls.
- BS in a science, engineering or related discipline.
- MS, CQE, or CRE preferred.
- Six Sigma Green or Black belt preferred.
- Minimum of 3 years experience preferred.
- Prefer experience with medical device product development lifecycle, including risk management and design/process verification and validation.
- Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
- Demonstrated ability to read and interpret CAD drawings.
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
- Thorough knowledge and understanding of US and International Medical Device Regulations.
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Must possess strong project management  skills as well as have the ability to manage multiple tasks simultaneously.
- Demonstrated ability to advocate for product excellence and quality.
- Demonstrated ability to effectively work cross-functionally with other departments, including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.
- Strong interpersonal skills, written, oral communication and negotiations skills.
- Strong in critical thinking and "outside the box" thinking.
- Highly developed problem solving skills. Strong analytical skills.
- Demonstrated ability to successfully manage and complete projects in a matrix organization.
- Demonstrated ability to work independently.
- Experience in working in a compliance risk situation.
- Computer literacy (including proficiency with Mini-Tab or similar analysis program).
- Some travel may be required.
Senior Advanced Quality Engineer · Stryker Employment Company, LLC