Associate Manager, Quality Engineering
Stryker Orthopaedics
Associate Manager, Quality Engineering
Join Stryker's Emergency Care business as an Associate Manager, Quality Engineering in Portage, MI supporting global complaint handling and post-market surveillance activities. In this leadership role, you will oversee quality programs, lead a team of Quality Engineers and Technicians, and partner across functions to ensure product quality, regulatory compliance, and continuous improvement. This position offers the opportunity to influence quality strategy, operational performance, and team development within a highly regulated medical device environment.
Workplace Flexibility: Candidate must reside within a commutable distance to Portage, MI which will be expected to be onsite at the facility Monday through Wednesday with optional remote days on Thursday and Friday depending on business needs.
What You Will Do
- Own talent strategy including hiring, workforce planning, performance management, and succession planning.
- Lead and develop a team of Quality Engineers and Technicians to achieve quality, compliance, and operational objectives.
- Represents Stryker in customer-facing quality discussions, partnering with sales and field teams to investigate concerns, communicate outcomes, and maintain customer trust.
- Establish and monitor key performance indicators (KPIs), quality objectives, and departmental goals.
- Partner with cross-functional teams to investigate, resolve, and communicate customer-impacting quality issues.
- Analyze complaint, warranty, and product quality data to identify trends, emerging risks, and improvement opportunities.
- Lead the development and implementation of complaint handling, post-market surveillance, and quality system processes.
- Support internal and external audits and ensure compliance with applicable regulatory requirements and quality standards.
- Manage departmental budgets and warranty-related costs while driving continuous improvement initiatives.
What You Will Need
Required Qualifications
- Bachelor's degree required. Bachelor's degree in engineering, science, or a related technical field strongly preferred.
- Minimum 6 years of experience in Quality Assurance, Research & Development, Regulatory Affairs, Service, or Operations within a regulated industry.
Preferred Qualifications
- Experience leading or managing technical teams, including employee development and performance management.
- Experience supporting compliance with U.S. and international medical device regulations and standards, including 21 CFR Part 820, ISO 13485, and ISO 14971.
- Experience leading process improvement, complaint handling, or post-market quality initiatives.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
$110.1k - $183.4k
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