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)