Staff Quality Engineer

Stryker - Inari Medical is hiring a Staff Quality Engineer in Irvine, California! In this role, you will lead quality assurance, control, and preventative activities with a focus on continuous product and process improvement. Additionally, you will drive and execute initiatives to enhance quality performance across the business and for customers while ensuring regulatory standards and compliance.

What You Will Do :

Work closely with operations, business functions, customers, sales, field personnel, marketing, and cross-functional teams to ensure product and process quality and resolve key quality issues.

Lead and support the integration of acquired companies into existing quality systems, including eQMS and ERP platforms. Act as a cross-functional liaison to ensure alignment and minimize system impacts across departments.

Collaborate with Training to develop and refine onboarding materials, documentation practices, and targeted training programs focused on compliance, quality culture, and process understanding.

Mentor and oversee NC / CAPA activities; lead problem-solving and root cause analysis efforts.

Support and lead closure of CAPAs, with a focus on streamlining processes and improving system usability.

Lead quality improvement initiatives across systems, processes, and procedures, with an emphasis on integration, compliance, and cross-functional alignment.

Lead quality issue investigations and provide strategic input by identifying process weaknesses and improvement opportunities.

Review and approve change management activities, challenge effectiveness, and drive thorough quality reviews.

Analyze KPI trends to drive continuous improvement and provide subject matter expertise in risk management.

Lead or support internal and external audits, including preparation and engagement with regulatory representatives.

Support manufacturing transfers to other plants / facilities, leading quality activities.

Support containment and support for potential product escapes.

Drive improvements in the electronic Quality Management System to enhance quality processes.

What You Need : Required :

BS in a science, engineering or related discipline.

4+ years of quality experience in a regulated industry required.

Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

Preferred : MS, CQE, or CRE.

Six Sigma Green or Black belt.

Medical device industry experience is strongly preferred.

Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).

Understanding of US and International Medical Device Regulations.

Familiarity with ISO 13485, GDP, GMP.

Proven ability to represent Quality across projects, with strong communication, problem-solving, critical thinking, and cross-functional collaboration skills in a matrix environment.

$100,700 - $165,100 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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 –

Work Flexibility : Onsite

Stryker - Inari Medical is hiring a Staff Quality Engineer in Irvine, California! In this role, you will lead quality assurance, control, and preventative activities with a focus on continuous product and process improvement. Additionally, you will drive and execute initiatives to enhance quality performance across the business and for customers while ensuring regulatory standards and compliance.

What You Will Do :

Work closely with operations, business functions, customers, sales, field personnel, marketing, and cross-functional teams to ensure product and process quality and resolve key quality issues.

Lead and support the integration of acquired companies into existing quality systems, including eQMS and ERP platforms. Act as a cross-functional liaison to ensure alignment and minimize system impacts across departments.

Collaborate with Training to develop and refine onboarding materials, documentation practices, and targeted training programs focused on compliance, quality culture, and process understanding.

Mentor and oversee NC / CAPA activities; lead problem-solving and root cause analysis efforts.

Support and lead closure of CAPAs, with a focus on streamlining processes and improving system usability.

Lead quality improvement initiatives across systems, processes, and procedures, with an emphasis on integration, compliance, and cross-functional alignment.

Lead quality issue investigations and provide strategic input by identifying process weaknesses and improvement opportunities.

Review and approve change management activities, challenge effectiveness, and drive thorough quality reviews.

Analyze KPI trends to drive continuous improvement and provide subject matter expertise in risk management.

Lead or support internal and external audits, including preparation and engagement with regulatory representatives.

Support manufacturing transfers to other plants / facilities, leading quality activities.

Support containment and support for potential product escapes.

Drive improvements in the electronic Quality Management System to enhance quality processes.

What You Need : Required :

BS in a science, engineering or related discipline.

4+ years of quality experience in a regulated industry required.

Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).

Preferred : MS, CQE, or CRE.

Six Sigma Green or Black belt.

Medical device industry experience is strongly preferred.

Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.).

Understanding of US and International Medical Device Regulations.

Familiarity with ISO 13485, GDP, GMP.

Proven ability to represent Quality across projects, with strong communication, problem-solving, critical thinking, and cross-functional collaboration skills in a matrix environment.

$100,700 - $165,100 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

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.

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