Quality Engineer

Quality Engineer

Work Flexibility: Hybrid

What you will do-

• Supports QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements).
• Develop and execute end-to-end change management plans aligned to OnePLM (CAI, CAII and CAIII) and engage in the development of optimum future state of QMS for business needs.
• Identify improvements and inputs into the quality planning process; execute development and/or modification of Stryker's QMS and support Management Review and Quality Planning Review and related forums, GMP and GDP within Quality organization.
• Assess and quantify requirements for QMS requirements to optimize structure.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Support implementation of best-in-class practices and benchmark against industry leaders and regulatory requirements and notified body communication; internal and external quality system audits; change control assessment and approval.
• Ensure QMS reflects actual activities, business needs and supports NPD requirement.
• Basic project management understanding and system integration.
• Key contributor to QMS business process(es) and support requirements.

What you will Need-

Required:

• BS in a science, engineering, business or related discipline.
• Experience - 2 years - 5 years in manufacturing environment or equivalent.

Preferred:

• Knowledge and understanding of US and International Medical Device Regulations.
• Advanced proficiency in Excel (pivot tables, complex formulas, data analysis) and Power BI (dashboards, reporting)
• Basic knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.); communication and project management skills.
• Strong interpersonal skills, written, oral communication and negotiations skills; Basic analytical and problem-solving capabilities.
• Demonstrated ability to work in cross-functional team environments.
• Some travel may be required.

Travel Percentage: None