Senior Quality Engineer, New Product Development (Hybrid)

About the position

Stryker is hiring a Senior Quality Engineer, New Product Development to support our Medical division. This is a hybrid position based in Cary, IL. As the Senior Quality Engineer, New Product Development you will lead quality engineering activities in the development of medical device and formulated products to ensure the highest level of product and process quality. You will provide guidance to the New Product Development teams to ensure compliance to the company's quality system and external standards.

Responsibilities

• Lead risk management activities for new product development teams by developing risk management files, conducting risk reviews, verifying implementation and effectiveness of risk controls.
• 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.
• 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.
• 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 where appropriate.
• Promote efficient testing practices.
• Support Advanced Operations in the development of manufacturing processes for new products including Production Part Approval Process (PPAP).
• 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 that may impact new product development projects.
• Analyze and define critical quality attributes for product and process through risk analysis techniques.

Requirements

• Bachelor's degree in science, engineering or related discipline
• Minimum 3 years' experience required
• Proficient understanding of Medical Device / Pharmaceutical manufacturing processes, FDA CFR 210, 211, and 820, ISO 13485, 14971, ICH Q7/Q10
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.)
• Demonstrated ability to read and interpret CAD drawings
• Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics)
• Strong project management skills along with ability to manage multiple tasks simultaneously

Nice-to-haves

• MS, CQE, or CRE preferred
• Six Sigma Green or Black belt preferred
• Experience with medical device and/or formulated 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
• Proficiency with Mini-Tab or similar analysis program