Engineering Manager, Post Market Quality

Workplace Flexibility

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

What you will do

• Provide strategic leadership and subject matter expertise for post-market quality systems, ensuring effective implementation, maintenance, and compliance with applicable global regulations, standards, and internal quality requirements.
• Lead, develop, and provide technical direction to a team of post-market quality engineers and professionals, fostering a customer-focused culture of accountability, collaboration, continuous improvement, and high performance.
• Own and oversee the end-to-end complaint handling and post-market surveillance processes, including complaint receipt, evaluation, investigation, trending, closure, and global regulatory reporting, including Medical Device Reporting (MDR) and Medical Device Vigilance (MDV).
• Establish strategic priorities, performance expectations, and quality objectives for the function, monitoring key metrics related to complaint investigations, regulatory reporting, complaint closure, emerging trends, and overall product quality performance.
• Apply advanced technical and regulatory expertise to interpret global post-market requirements, assess reportability, identify compliance risks, and lead the 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, data analysis, and identification of emerging quality signals, translating findings into actionable recommendations and communicating significant product quality issues and performance trends to business and quality leadership.
• Serve as the post-market quality subject matter expert and process owner, representing the function during internal and external audits, Management Reviews, regulatory interactions, and other critical quality and compliance activities.
• Drive continuous improvement and organizational capability by advancing post-market processes, providing training and guidance to key stakeholders, and ensuring 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, while managing resources, budget, expenses, and capital needs to support business and quality objectives.

What you will need

Required:

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

Preferred:

• Master’s degree preferred.
• Certified Quality Engineer/Auditor 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.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook; experience with advanced Excel functionality, database management, and statistical analysis software (e.g., Minitab) preferred.