Engineering Manager, Post Market Quality

Stryker•Tempe, AZ

3d•Hybrid

About The Position

Stryker is hiring an Engineering Manager, Post Market Quality for its Sustainability Solutions business unit within the Endoscopy division. The role provides strategic and operational leadership for global post-market quality processes, including product quality, failure analysis, design improvements, complaint handling, regulatory reporting, and post-market product surveillance. The manager leads a team of post-market quality engineers and professionals and owns complaint handling and surveillance processes from receipt through evaluation, investigation, trending, closure, and global regulatory reporting. The position also provides functional leadership for the Complaint Handling organization and Complaint Investigation Laboratory, including oversight of resources, budget, expenses, and capital needs. The manager partners with customers and cross-functional teams to resolve complex product quality issues, improve product and process performance, identify emerging quality signals, and ensure compliance with applicable regulations, standards, and internal quality requirements. The role represents post-market quality in audits, Management Reviews, regulatory interactions, and other quality and compliance activities, while advancing processes, training, and consistent global adherence to quality policies and procedures. The candidate must live within commuting distance of Tempe, Arizona, and is expected to work onsite at the facility three to four days per week. Travel is 10%.

Requirements

Bachelor’s degree in engineering or science.
At least 8 years of professional experience in Quality, Research & Development (R&D), or a related function in a cGxP-regulated or similarly highly regulated environment.
Technical foundation and experience in post-market quality, pre-market/New Product Development (NPD), engineering, operations, or a related function, with the ability to apply technical knowledge to complex product and quality issues.
At least 3 years of experience directly supervising or managing personnel, including technical professionals, with responsibility for team development, work prioritization, and cross-functional initiatives in engineering, quality, operations, or a related technical function.
Ability to reside within commuting distance of Tempe, Arizona.

Nice To Haves

Master’s degree.
Certified Quality Engineer or Certified Quality Auditor.
Working knowledge of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820; ISO 13485; ISO 14971; European Medical Device Directive (93/42/EEC); Canadian Medical Devices Regulation (SOR/98-282); and Japanese MHLW Ordinance 169.
Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.
Experience with advanced Excel functionality, database management, and statistical analysis software such as Minitab.

Responsibilities

Provide strategic leadership and subject matter expertise for post-market quality systems, ensuring implementation, maintenance, and compliance with global regulations, standards, and internal quality requirements.
Lead, develop, and provide technical direction to post-market quality engineers and professionals, fostering accountability, collaboration, continuous improvement, customer focus, and high performance.
Own and oversee end-to-end complaint handling and post-market surveillance, including complaint receipt, evaluation, investigation, trending, closure, and global regulatory reporting, including MDR and MDV.
Establish strategic priorities, performance expectations, and quality objectives; monitor metrics related to investigations, regulatory reporting, complaint closure, emerging trends, and product quality performance.
Interpret global post-market requirements, assess reportability, identify compliance risks, and lead development and improvement of policies, procedures, systems, and operational practices.
Partner with customers, Field Sales, Marketing, Operations, Technical Service, and other cross-functional leaders to resolve complex product quality issues, drive timely complaint and CAPA/non-conformance closure, and improve product and process performance.
Lead complaint trending and data analysis, identify emerging quality signals, translate findings into recommendations, and communicate significant quality issues and trends to business and quality leadership.
Serve as post-market quality subject matter expert and process owner during internal and external audits, Management Reviews, regulatory interactions, and other quality and compliance activities.
Advance post-market processes, provide training and guidance to stakeholders, and promote consistent global understanding and adherence to quality policies and procedures.
Provide functional and operational leadership for the Complaint Handling organization, including the Complaint Investigation Laboratory; manage resources, budget, expenses, and capital needs.