Associate Manager, Quality Engineering

Posted 13 Days Ago
Be an Early Applicant
Portage, MI, USA
In-Office
110K-183K Annually
Senior level
Healthtech
The Role
Leads quality engineering teams and programs supporting medical device complaint handling, post-market surveillance, regulatory compliance, audits, quality system processes, and continuous improvement. Analyzes complaint and product quality data, manages KPIs, budgets, and warranty costs, investigates customer-impacting issues, and partners cross-functionally with sales and field teams. Oversees talent strategy, team development, and operational performance in a regulated environment.
Summary Generated by Built In
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

View the U.S. work location and transparency guide to find the pay range for your location.

  


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.

Skills Required

  • Bachelor's degree required
  • Bachelor's degree in engineering, science, or a related technical field
  • Minimum 6 years of experience in Quality Assurance, Research and Development, Regulatory Affairs, Service, or Operations within a regulated industry
  • 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

Inari Medical Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.

  • Fair & Transparent Compensation Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
  • Healthcare Strength Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
  • Leave & Time Off Breadth Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.

Inari Medical Insights

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The Company
HQ: Irvine, CA
956 Employees

What We Do

Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.

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