Zimmer Biomet · 7 hours ago
Quality Assoc Manager
Warsaw, IN
Full-time
Hybrid
Senior Level
5+ years expZimmer Biomet is a global medical technology leader dedicated to enhancing patient mobility. The Quality Associate Manager will manage document control and quality management systems, ensuring compliance with medical device regulations while leading projects to implement automated quality systems.
Health CareManufacturingMedical DeviceProduct Design
Responsibilities
Manage the document control and learn management system and function
Conduct compliance train under minimal supervision
Maintain document control program and product release function to ensure compliance to domestic and international medical device regulations
Manage the identification, implementation, and support of automated tools to support the quality management processes
Manage projects related to the introduction and support of automated quality systems
Ensure compliance of automated quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation
Maintain records of training documentation according to organizational and regulatory requirements
Assure all departments have effective assigned training to ensure compliance with regulatory and job skill requirements
Ensure that all applicable personnel are trained on new or revised internal procedures
Pursue and monitor corrective and preventive actions for applicable processes
Coordinate department in creation of device master records
Coordinate the archival of device master records and device history records to demonstrate compliance to GMP, ISO, and MDD regulations
Assist department efforts in audits, both internal and external, to demonstrate compliance with GMP, ISO, and MDD regulations
Manage the change control program
Assist implementation of quality improvement projects
Coordinate department efforts for annual archival of records to offsite storage facility
Qualification
Required
Must have 5 years of experience in job offered or related position
Must Have 3 Years Of Experience In The Following: FDA regulated industry experience; and total engineering project experience including leading CAPA process use DMAIC methodology
Must Have 2 Years Of Experience With The Following: Apply statistical analysis for quality control/assurance and CAPA verification of effectiveness plan; review and approve CAPA metrics and quality system records in a manner complaint with 21 CFR Part 820 & part 11 regulations and IS013485; ISO quality systems auditing; presenting to a non-technical audience; provide training to a technical audience; and lean manufacturing projects
Requires a Bachelor's in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related field
Benefits
Development opportunities
Robust employee resource groups (ERGs)
A flexible working environment
Location specific competitive total rewards
Wellness incentives
A culture of recognition and performance awards
Company
Zimmer Biomet
Zimmer Biomet is a medical device manufacturing company that offers orthopedic reconstructive, spinal, and trauma devices.
10001+ employees
H1B Sponsorship
Zimmer Biomet has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$2.75B2025-02-20Post Ipo Debt· $1.75B
2016-12-14Post Ipo Debt· $1B
2001-08-03IPO
Leadership Team
Ivan Tornos
Chairman, President and CEO
D
David DeMartino
Senior Vice President, Investor Relations
Recent News
2026-01-13
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2025-12-19
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