Manager, Divisional Post Market Quality (Hybrid)

Stryker is hiring a Manager, Divisional Quality (Hybrid) in Portage, MI! The Manager, Divisional Quality is responsible for supporting product quality after initial product launch through post-market quality investigations, as well as improving the effectiveness and efficiency of quality systems associated with post-market quality investigations, adverse event reporting, commercial holds, and post market data analytics.

Workplace Flexibility: Candidate must reside within a commutable

distance to Portage, Michigan but is expected to be onsite at the facility multiple times/week.

Who we want:

• Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

• Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.

• Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

What you will do:

• Provide leadership, support, mentorship, and direct management of Post-Market quality process owners (complaints, adverse events, etc.) and specialists within Divisional Quality. These resources are responsible for assessing post-market risk assessments, and supporting/conducting post-market investigations through quality systems such as complaints, adverse events, NC, CAPA, Commercial Holds, Health Hazard Evaluations, and PFA assessments.

• Drive, maintain engagement, and coach/develop direct reports.

• Develop, measure, and report key quality metrics to drive quality and efficiency.

• Develop, implement, and maintain effective and efficient processes and systems to achieve metrics and goals.

• Responsible for trending and analysis of post market product data and providing updates to Division leadership

• Create and maintain a culture of partnership, transparency, service, and collaboration with adjoining groups and teams.

• Work closely with the Operations, Product Engineering, Supplier Teams, Distribution, etc. to provide support for technical issues that may be encountered.

• Support planning and execution of Division RA/QA initiatives.

• Responsible oversight of quality system processes within scope of team for all Instruments’ sites.

• May interact or supervise team interaction with customers either via telephone or in person to solve product issues and/or answer general product questions.

• Initiate training programs to advance understanding of QMS requirements and quality concepts.

• Support Division RA/QA with internal and 3rd party audits, as applicable.

What you need:

Required

• Bachelor's Degree required

• 8+ years of professional experience working in Quality or Regulatory.

• 2+ years of experience supervising or managing direct reports.

• Excellent written and verbal skills.

Preferred

• Master's Degree from a four-year college or university.

• Working knowledge of FDA/QSR, ISO 13485, ISO14971, and quality tools and methods.

• Intermediate user in Microsoft Office suite (Word, Excel, PowerPoint, Outlook)