Associate Manager, Quality Engineering

Stryker; Portage (MI); Hybrid; USD 110,000 - 183,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) plan

ESPP

Life insurance

Short-term disability

Job summary

Stryker in Portage, MI is seeking an Associate Manager, Quality Engineering to lead a team of Quality Engineers and Technicians, oversee complaint handling, post-market surveillance, and quality systems within a highly regulated medical device environment.

This role focuses on shaping quality strategy, driving KPIs, and partnering across functions to ensure regulatory compliance, product quality, and continuous improvement, with onsite Tue-Wed and optional remote days depending on business needs.

Qualifications

• Bachelor's degree in engineering, science, or related technical field.
• Minimum 6 years of experience in a regulated quality environment.
• Experience with quality systems and regulatory requirements.

Responsibilities

• 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 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 regulatory requirements and quality standards.
• Manage departmental budgets and warranty-related costs while driving continuous improvement initiatives.

Skills

Team leadership

Quality assurance

Regulatory compliance

Data analysis

Cross-functional collaboration

Education

Bachelor's degree in engineering/science

Job description

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

• 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.

USN

$110,100 - $183,400 USD Annual

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Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.