Senior Advanced Quality Engineer

Stryker Corporation; Carrigtohill; On-site; Confidential; Full time

Job summary

Stryker Corporation seeks a Lead Quality Engineer to drive quality activities across the New Product Development lifecycle. You will develop QA documentation, maintain the design control system, and participate in design reviews to identify risks and mitigation strategies.

The role requires extensive collaboration with cross‑functional teams to ensure regulatory readiness and product integrity. The ideal candidate has a science/engineering background with 3+ years in medical devices, strong

Qualifications

• BS in science, engineering, or related discipline is required.
• Master’s, CQE, or CRE preferred to support advanced QA activities.
• Minimum 3 years of relevant experience in medical device quality.

Responsibilities

• Develop quality assurance documentation to support new product development and regulatory submissions.
• Support quality system maintenance for design control by correcting deficiencies in procedures.
• Engage in design, development, manufacturing, and risk management activities.
• Participate in design reviews to identify risks and track mitigation across development.
• Define design verification and validation test requirements with objective evidence.
• Complete final V&V reports with concise conclusions and statistical support.
• Promote efficient testing practices and support manufacturing process development.
• Utilize standard statistical methods to set acceptance limits and resolve quality problems.
• Develop, review, and approve inspection plans, routers, and drawings for new products.
• Support product design transfers to internal/external manufacturing facilities.
• Evaluate predicate products for quality issues impacting new developments.
• Analyze and define critical quality attributes through risk analysis.
• Collect market feedback on new products and address early concerns.
• Lead risk management plans, reviews, and verify effectiveness of controls.

Skills

Quality system adherence

Risk management

Design for quality

Statistical analysis

Regulatory knowledge

Communication skills

Education

Bachelor of Science in science/engineering

Master’s, CQE, or CRE preferred

Tools

MiniTab

Job description

Overview

Lead Quality Engineering activities in the development of products to ensure the highest level of product and process quality. Provide guidance to the New Product Development teams to ensure compliance with the company's quality system and external standards.

Key Responsibilities

• 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.
• Participate in design reviews by identifying risks associated with the product and tracking how the design, documentation, and manufacturing process mitigate those issues throughout the development process.
• Define design verification and validation test requirements that ensure objective evidence is available to support the acceptance criteria.
• Complete final design verification and validation reports with concise conclusions, statistical validity, and graphical support.
• Promote efficient testing practices and 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, and resolve quality problems.
• 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.
• Collect initial market feedback on new products and address early concerns.
• Lead risk management activities by developing risk management plans and reports, conducting risk reviews, and verifying implementation and effectiveness of risk controls.

Education / Experience

• Bachelor of Science in a science, engineering or related discipline (required).
• Master’s, CQE, or CRE preferred.
• Minimum 3 years experience preferred.

Knowledge & Competencies

• Experience with medical device product development lifecycle, including risk management and design/process verification and validation.
• Applied knowledge of advanced quality tools such as FMEA, GD&T, Root Cause Analysis, and Mistake Proofing/Poka Yoke.
• Ability to read and interpret CAD drawings.
• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.) and thorough knowledge of US and International Medical Device Regulations.
• Strong knowledge of quality concepts (e.g., CAPA, audits, statistics).
• Project management skills and ability to manage multiple tasks simultaneously.
• Strong interpersonal, written, oral, and negotiation skills.
• Critical thinking, problem solving, analytical skills, and ability to think “outside the box.”
• Experience managing projects in a matrix organization and working independently.
• Experience in compliance risk situations.
• Computer literacy, including proficiency with Mini-Tab or similar analysis program.

Travel

Some travel may be required. Travel percentage: None.