Senior Engineer, Post-Market Quality (Hybrid)

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Tempe, AZ 85280, United States
Job details
Work flexiblity: Hybrid or Onsite Req ID: R523127 Employee type: Full Time Job category: Engineering Travel: 10% Relocation: No

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Why join Stryker?

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Job description

Stryker is hiring a Senior Engineer, Post- Market Quality (Hybrid) for our Sustainability Solutions team supporting our Endoscopy product line, who will provide quality engineering support and direction in quality assurance, complaint handling, investigations, and support post-market product surveillance activities. Drive preventative activities with a focus on continuous improvement of products and processes. Including advocating and leading the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance with regulations and standards.

Workplace Flexibility: Candidate must reside within a commutable distance to Tempe, AZ but is expected to be onsite at the facility multiple times/week.

Who we want-

  • Patient-oriented achievers. Individuals with an unparalleled work ethic and customer-focused attitude who bring value to their partnerships.

  • Charismatic networkers. Relationship-savvy people who intentionally make connections with both internal partners and external contacts.

  • Challengers & Influencers.  People who constantly challenge themselves and each other to achieve more & to win the right way.

  • Teammates.  Partners who listen to ideas, share thoughts, and work together to move the business forward.

What you will do:

Develop and deploy methodologies and protocols for process control, enhancement, testing, and inspection, guaranteeing flawlessness and optimal functionality of products. Install and oversee advanced testing apparatus, conducting thorough product assessments to uphold quality standards and reduce defect rates. Analyze both reports and faulty products to identify patterns and propose corrective measures. Collaborate with suppliers to address quality issues, ensuring swift and effective resolutions while actively contributing to supplier quality enhancement initiatives.

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

  • Work closely with operations and the business functions to ensure quality performance of product and processes.

  • Ownership and Approval of NC/CAPA, builds proficiency in problem-solving and root-causing activities.

  • Engage in the development and improvement of the manufacturing processes for existing products.

  • Review of change management activities.

  • Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.

  • Support execution and analysis of complaints and product field actions.

  • Advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.

  • Develop understanding of risk management practices and concepts.

  • Develop understanding of optimization of inspection methods and sampling.

  • Develop proficiency in statistical methods and application.

  • Engage and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.

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

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

What you will need

Required:

  • Bachelor’s degree in science or an engineering discipline with a minimum of 3+ years of professional work experience working in a regulated environment.

Preferred:

  • Previous medical device industry experience preferred 

  • Familiarity with Quality Concepts such as Risk Management, CAPA, Audits, Statistics.

  • Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.

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

  • Understanding of US and International Medical Device Regulations, including ISO 13485, GDP, GMP.

  • Strong communication, project management, and influencing skills required, with the ability to manage multiple tasks simultaneously.

  • Ability to effectively represent the Quality function within project teams.

  • Excellent interpersonal, written, and oral communication skills, including negotiation abilities.

  • Proficiency in critical and creative problem-solving, with strong analytical skills.

  • Demonstrated success in managing and completing projects within a matrix organization.

  • Ability to work both independently and collaboratively within cross-functional teams.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role. Apply Now