Manager, Quality Systems (Remote, Hybrid, or Onsite)

Stryker is hiring a Manager, Quality Systems (Remote, Hybrid, or Onsite), in Redmond, Washington to support Medical! In this role, you will establish a quality center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. In addition, you will oversee and ensure that an effective and efficient quality management system is built and maintained while providing technical leadership on a regional and global level. Additionally, you will be responsible for ensuring that all applicable quality system regulations are met in order to receive regulatory clearance/certification.

Work Flexibility: Remote, Hybrid, or Onsite. It is preferred that this person is in reasonable proximity to our Stryker facility in Redmond and is comfortable working 3 days onsite.

What you will do:

• Manage day-to-day quality systems processes to ensure issues are appropriately evaluated, including document control, quality audit, NC/CAPA, device tracking.

• Ensure 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). Monitor changes in regulatory requirements.

• Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.

• Provide direction for the overall QMS strategy. Lead improvement processes, executing and leading projects.

• Provide guidance to identify and deliver strategic and futuristic improvements and inputs into the quality planning process.

• Oversee identification and implementation of improvement opportunities to increase the efficiency and effectiveness of the QMS.

• Ensure optimum state of QMS for current and future business needs.

• Liaise with global and corporate partners to provide best-in-class global solutions and input into processes.

• Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.

• Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.

• Ensure development and delivery of training for QMS areas of expertise.

• Oversee and/or manage Management Review and Quality Planning Review and related forums.

• Establish standard process to ensure appropriate resolution and management of the responsible task owner.

• Chair meetings required to drive closure of quality issues.

• Manage and provide updates for quality metrics. Implement appropriate enhancements.

• Represent quality processes during internal and external audits.

• Represent quality systems for IS system integrations.

• Understand and contribute to the development and generation of IS compliance and validation documentation.

• Recruit, manage, and develop a high-performing team, ensuring engagement and developing talent within team to increase performance.

What you need:

Required:

• Bachelor’s degree required.

• 8+ years’ experience in manufacturing environment or related.

• Experience in regulated environment and interaction with regulatory agencies.

Preferred:

• Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

• Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.

• Demonstrated ability to develop and implement global strategies. Initiates, sponsors, and implements changes with a demonstrated track record.

• Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience.

• Demonstrated ability to collaborate effectively with and lead cross-functional teams.

• Demonstrated ability to effectively prioritize and manage multiple project workloads.

• Demonstrated experience with trending and analysis reporting.

• Demonstrated leadership skills.

• Experience with recruiting, people development.

• Demonstrated process improvement and management skills.

$112,800 - $239,900 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.