Engineering Manager, Post Market Quality (Hybrid)

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Tempe, AZ 85280, United States
Job details
Work flexiblity: Hybrid or Onsite Req ID: R523124 Employee type: Full Time Job category: Engineering Travel: 20% Relocation: Yes

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Why join Stryker?

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Job description

Stryker is hiring an Engineer Manager, Post Market Quality (Hybrid) for our Sustainability Solutions division supporting Stryker’s Endoscopy products. This Manager will lead the global business processes related to product quality, failure analysis, design improvements, complaint handling, and regulatory reporting and supports the post-market product surveillance activities.

Workplace Flexibility:

Candidate must reside within a commutable distance to Tempe, AZ, and is expected to be onsite at the facility multiple 3-4 days/week.

Who we want:

  • Patient-oriented achievers. Leaders 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:

Provides leadership and subject matter expertise to ensure that an effective system is successfully implemented and maintained to ensure compliance in global markets; requires strong communication and problem-solving skills as well as a solid understanding of applicable global regulations and standards. Provide engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of products and processes. Advocate and provide leadership in the execution of initiatives and projects to enhance quality performance within the business and for our customers. Ensure compliance with regulations and standards.

  • Build a strong customer-centric engineering team that works to resolve field issues and improve product quality.

  • Leads a team of post-market engineers and professionals in meeting global regulations in the areas of post-market complaint handling, global reporting, and trending.

  • Strong understanding of customer needs and demonstrate technical leadership.

  • Thrives in a fast-paced environment.

  • Ensures timely and compliant management of complaint receipt, evaluation, and investigation processes.

  • Provide strategic planning and tactical direction to the team to meet predefined metrics and quality objectives (e.g., complaint investigation completion time metrics, on-time regulatory reporting metrics, and complaint closure metrics).

  • 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 products and processes.

  • Responsible for all post-market reporting to global regulatory authorities including Medical Device Reporting (MDR) and Medical Device Vigilance (MDV) reporting.

  • Interprets regulations for execution and recommends modifications to operational procedures to ensure continued compliance.

  • Maintain current knowledge of regulatory worldwide requirements for adverse event reporting.

  • Communicates complaint investigation results in a timely manner to customers and to external regulatory agencies.

  • Represent area as a subject matter expert in support of internal and external audits.

  • Provides training to Technical Service and Technical Support teams to ensure compliance with post-market surveillance requirements.

  • Works with key partners to ensure global awareness and adherence to policy and procedures.

  • Develops, maintains, and advances policy and procedures to support business and compliance needs.

  • Ensures appropriate investigations regarding reportability are initiated and documented; provides leadership and oversight of complaint trending and data analytics.

  • Support Field Sales Business Reviews by providing success rate reports and complaint analysis.

  • Create a culture of partnership, transparency, service, and collaboration with field personnel.

  • Process Owner for complaint system and Medical Device Reporting (MDR)/Medical Device Vigilance (MDV) reporting for the business.

  • Submit periodic reports to leadership on key quality metrics and emerging product quality issues and present data at Management Review meetings.

  • Manage budget, control expenses, and develop/initiate capital needs.

  • Communicate in an effective and timely manner with Division and Global Quality & Operations (GQO) leaders regarding the effective implementation of complaint issues.

  • Maintain procedures to ensure compliance with corporate policies and applicable global regulations.

  • Partner with other departments throughout the organization to ensure timely closure of complaints and non-conformances/CAPA.

  • Provides functional management for the Complaint Handling team, including the Complaint Investigation Laboratory

  • Other duties as assigned by the manager.

What you will need

Required:

  • Bachelor’s degree in engineering or science is required.

  • A minimum of 9+ years of overall professional work experience in a highly regulated environment (preferably in the Medical device industry) with 3+ years of experience supervising/managing personnel.

Preferred:

  • Master’s degree preferred.

  • Experience in Quality, Regulatory, or R&D preferred.

  • Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169

  • Management experience, experience managing technical personnel and complex activities (e.g., engineering, technical operations) preferred.

  • Excellent interpersonal skills, and ability to work with individuals across all levels of management and customers. Demonstrated effective managerial skills and strong team leadership skills.

  • Ability to take initiative, maintain confidentiality, meet deadlines, and to work in a team environment is essential. Strong written and oral communication skills.

  • Excellent analytical skills, data collection, management and reporting skills.

  • Demonstrated ability to lead high-performing teams and facilitate problem-solving and cross-functional teams.

  • Demonstrated ability in customer problem resolution and strong customer focus.

  • Demonstrated ability to justify, procure, and implement major capital equipment for the investigation lab.

  • Proficient in Microsoft Word, Excel, PowerPoint, and Outlook; strong Excel skills and Database Management preferred.

  • Certified Quality Engineer/Auditor preferred.

  • Statistical software (e.g. MiniTab) experience preferred.

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