Associate Manager, Quality Engineering

Stryker•San Jose, CA

3d•Hybrid

About The Position

Stryker is hiring an Associate Manger, Quality Engineering in San Jose, CA supporting our Endoscopy division, who will manage and coordinates Quality engineering responsibilities for a team of quality engineers and/or technicians.

Requirements

Bachelor’s degree in an Engineering related discipline
Minimum of 6 years of engineering experience in a regulated environment
Working knowledge of one or more of the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820, and/or ISO 14971 risk management.

Nice To Haves

Master’s degree in an Engineering related discipline
1+ years of demonstrated experience leading high‑performing teams with strong leadership and effective interpersonal communication skills

Responsibilities

Provide full people management responsibility for salaried and/or hourly Quality team members, including performance management, talent reviews, development planning, and employee engagement.
Build and maintain a high-performing, engaged team through regular 1:1s, clear performance objectives, and alignment to business strategy and quality goals.
Own Quality staffing strategy, including hiring, talent development, workload prioritization, and coordination of direct report activities.
Drive continuous improvement by establishing KPIs, monitoring metrics, and implementing process improvement methodologies across the Quality organization.
Partner cross-functionally with Project Managers, Engineering, and other functional leaders to ensure appropriate resourcing and quality support for programs and projects.
Support new product development and lifecycle management activities, including design support, change control review, and ensuring launches meet quality, regulatory, and user requirements.
Oversee Quality System execution, including complaint handling, MDR/MDV reporting, CAPA/NC review, product ship holds, and product field action decisions.
Serve as a subject matter expert in applicable domestic and international regulations and standards (e.g., FDA QSR, ISO 13485), including participation in FDA and Notified Body inspections.