Job Details

Stryker

http://www.stryker.com

Associate Manager, Quality Engineering

Occupation: Engineering and Architecture

Specialty: Architectural Engineering

Visa sponsorship provided: No

Location: Portage, Michigan, United States

Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Stryker is actively seeking to hire a full-time, Associate Quality Manager to work in Portage, Michigan.

Who we want

Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.
Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

What you will do

Lead the Customer Quality team of Engineers and Technicians to ensure regulatory compliance in Post Market Surveillance (ie Complaint Handling and Adverse Event Reporting) while driving effective and efficient solutions for our customers.
Responsible for talent management including hiring, coaching, engaging, and developing QA professionals
Provide internal and external audit support including direct interactions with auditors on process and record review as needed to supplement subject matter experts
Lead the development of new systems and procedures
Monitor worldwide regulations and drive proactive change
Collaborates with other functional groups to ensure timely and effective solutions to our customers.
Works as a key member of an interdisciplinary business team to drive business performance.

What you need

Bachelor’s Degree in Engineering or related field of study

Qualifications & Experience

5+ years of experience in Quality Assurance, R&D, Regulatory, or associated field in a regulated industry
Experience mentoring and interviewing candidates preferred
Managing experience in quality engineering, research, and development, quality assurance, regulatory affairs, or associated field preferred.
Possesses and applies a broad knowledge of principles, practices, and procedures to ensure conformance to US and international standards, regulations, and initiatives. (CFR part 820, ISO-13485, ISO-14971, etc.)
Basic skills - Time management, project management, reports and budget, stress management, conflict management, re-engineering, customer service, ISO, Windows, PC literate.
Ability to make decisions impacting team members regarding training, coaching/counseling, and appropriate follow-up.
Ability to make decisions regarding compliance issues, product reliability, and analysis of testing methodologies.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.