Associate Manager, Quality Engineering

Stryker; Town of Portage (NY); Hybrid; USD 110,000 - 183,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Stryker’s Emergency Care business in Portage, MI is seeking an Associate Manager, Quality Engineering to lead a team of Quality Engineers and Technicians, oversee quality programs, and partner across functions to ensure product quality and regulatory compliance.

You will drive complaint handling, post-market surveillance, audits, and continuous improvement while managing budgets and cross-functional collaboration to strengthen customer trust and quality outcomes.

Qualifications

• Bachelor’s degree in engineering, science, or related technical field preferred.
• Minimum 6 years in Quality Assurance, R&D, Regulatory Affairs, Service, or Operations within a regulated industry.

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.
• Represent Stryker in customer-facing quality discussions with sales and field teams.
• Establish and monitor KPIs, quality objectives, and departmental goals.
• Investigate, resolve, and communicate customer-impacting quality issues with cross-functional teams.
• Analyze complaint, warranty, and product quality data to identify trends and risks.
• Lead development and implementation of complaint handling and post-market surveillance processes.
• Support audits and ensure compliance with regulatory requirements and standards.
• Manage departmental budgets and warranty-related costs while driving improvements.

Skills

Leadership

Quality Engineering

Regulatory Compliance

Continuous Improvement

Team Development

Budget Management

Education

Bachelor's degree in engineering or related technical field

Tools

Quality Management Systems

Job description

Work Flexibility: Hybrid

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.

USN : $110,100 - $183,400 USD Annual

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Travel Percentage: 20%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.