Senior Staff Quality Engineer

Regulatory Jobs; San Jose (CA); Hybrid; USD 133.000 - 222.000; Vollzeit

Zusammenfassung

Stryker is hiring a Senior Staff Quality Engineer in the Endoscopy division, based in San Jose, CA. You will provide quality engineering leadership across QA, QC and preventive activities, driving continuous improvement of products and processes to meet regulatory requirements.

You will mentor teams, lead NC/CAPA activities, manage audits, and ensure compliance with ISO 13485, GMP and post-market requirements while partnering with customers and cross-functional teams to resolve top quality

Qualifikationen

• Bachelor’s degree in science, engineering or related discipline.
• Minimum 6 years of experience in Quality and/or R&D within the medical device industry.
• Strong knowledge of ISO 13485, GDP, GMP and U.S./international medical device regulations.
• Experience leading root cause investigations, CAPA, complaint investigations and post-market quality initiatives.

Aufgaben

• Lead quality initiatives and projects across the organization.
• Mentor teams and provide technical direction on NC/CAPA, investigations and risk management.
• Engage in internal and external audits with regulatory representatives and manage audit logistics.

Kenntnisse

Quality assurance

Medical device

Root cause investigations

CAPA

Regulatory compliance

Ausbildung

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Jobbeschreibung

Work Flexibility: Hybrid

Stryker is hiring a Senior Staff Quality Engineer for our Endoscopy division in San Jose, CA to provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulation and standards.

What you will do

• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.

• Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.

• Leads quality initiatives or projects.

• Recognized process owner, with expertise across multiple quality areas.

• Provides input into local, global, and corporate processes, represents function on review boards and teams.

• Review and approval of change management activities, challenges effectiveness and drives strong review.

• Interpret KPI trends, drive continuous improvement process.

• Advocate of Human Factor practices, proficiency in the science of identification of mitigation.

• Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.

• Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.

• Coach and mentor others in quality topics and activities.

Required

• Bachelor’s degree in a science, engineering or related discipline.

• Minimum 6 years of experience in Quality and/or Research & Development (R&D) within the medical device industry, supporting product development, design controls, risk management, quality systems, and post-market surveillance activities.

• Strong knowledge of medical device quality and regulatory requirements, including ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), post-market compliance requirements, and U.S. and international medical device regulations.

• Experience leading and supporting root cause investigations, nonconformance management, CAPA activities, complaint investigations, and post-market quality initiatives to drive continuous improvement and regulatory compliance.

Preferred

• Masters degree

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

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

• ASQ Certified Quality Engineer (CQE) and/or Certified Reliability Engineer (CRE) certification preferred.

• Six Sigma Green Belt or Black Belt certification preferred, with demonstrated application of continuous improvement and process optimization methodologies.

$133,400 - $222,300 USD Annual

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.