Associate Manager, Quality Engineering

Posted 2 Hours Ago
Be an Early Applicant
San Jose, CA, USA
In-Office
133K-222K Annually
Senior level
Healthtech
The Role
Manage and coordinate quality engineering responsibilities for a team, drive continuous improvement, oversee compliance with regulations, and support product development.
Summary Generated by Built In
Work Flexibility: Hybrid or Onsite

Stryker is hiring an Associate Manger, Quality Engineering in San Jose, CA supporting our Endoscopy division, who will manage and coordinates Quality engineering responsibilities for a team of quality engineers and/or technicians.

What you will do:

  • Provide full people management responsibility for salaried and/or hourly Quality team members, including performance management, talent reviews, development planning, and employee engagement.

  • Build and maintain a high-performing, engaged team through regular 1:1s, clear performance objectives, and alignment to business strategy and quality goals.

  • Own Quality staffing strategy, including hiring, talent development, workload prioritization, and coordination of direct report activities.

  • Drive continuous improvement by establishing KPIs, monitoring metrics, and implementing process improvement methodologies across the Quality organization.

  • Partner cross-functionally with Project Managers, Engineering, and other functional leaders to ensure appropriate resourcing and quality support for programs and projects.

  • Support new product development and lifecycle management activities, including design support, change control review, and ensuring launches meet quality, regulatory, and user requirements.

  • Oversee Quality System execution, including complaint handling, MDR/MDV reporting, CAPA/NC review, product ship holds, and product field action decisions.

  • Serve as a subject matter expert in applicable domestic and international regulations and standards (e.g., FDA QSR, ISO 13485), including participation in FDA and Notified Body inspections.

What you need:

Required

  • Bachelor’s degree in an Engineering related discipline

  • Minimum of 6 years of engineering experience in a regulated environment, with working knowledge of one or more of the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820, and/or ISO 14971 risk management.

Preferred

  • Master’s degree in an Engineering related discipline

  • 1+ years of demonstrated experience leading high‑performing teams with strong leadership and effective interpersonal communication skills

  


$133,400 - $222,300 USD Annual

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

  


Travel Percentage: 10%

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 in an Engineering related discipline
  • Minimum of 6 years of engineering experience in a regulated environment
  • Working knowledge of standards like ISO 9001, ISO 13485, FDA regulations

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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