Quality Assoc Manager (7218) at Zimmer Biomet
Zimmer Biomet · Warsaw, United States Of America · Onsite
- Professional
- Office in Warsaw
Career Opportunities: Quality Assoc Manager (7218)
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
Manages the Document Control and Learning Management System and function. Compliance Training Under minimal supervision, maintains Document Control program and Product Release function to ensure compliance to domestic and international medical device regulations. Manages the identification, implementation, and support of automated tools to support the quality management processes.
This is an on-site position in Warsaw Indiana, Monday - Friday, 8-5pm EST.
How You'll Create Impact
- Manages projects related to the introduction and support of automated quality systems.
- Ensures compliance of automated quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation.
- Maintaining 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
- Ensuring that all applicable personnel are trained on new or revised internal procedures
- Pursues and monitors 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 Change Control program
- Assists implementation of quality improvement projects.
- Coordinate department efforts for annual archival of records to offsite storage facility.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
- Position requires extensive knowledge of Zimmer Biomet processes, Zimmer Biomet business practices, and Zimmer Biomet business management systems.
- Extensive knowledge of the Quality System Regulation and Associated regulations and standards.
- Individual must be familiar with use of PLM (Product Life Cycle Management) & ERP.
- Requires hands on system and quality system process experience.
- Excellent oral and written skills required.
Your Background
- BA in and engineering or computer science discipline, or
- Bachelor degree in another field with related certifications (e.g. CMM, CQE) plus 5-7 years’ experience in a quality engineering or regulatory compliance role
- One or more years supervising/managing a team is strongly preferred.
Travel Expectations
Up to 10%
EOE
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
Manages the Document Control and Learning Management System and function. Compliance Training Under minimal supervision, maintains Document Control program and Product Release function to ensure compliance to domestic and international medical device regulations. Manages the identification, implementation, and support of automated tools to support the quality management processes.
This is an on-site position in Warsaw Indiana, Monday - Friday, 8-5pm EST.
How You'll Create Impact
- Manages projects related to the introduction and support of automated quality systems.
- Ensures compliance of automated quality systems to the QSR, other applicable regulations/standards, and internal procedures, including but not limited to validation.
- Maintaining 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
- Ensuring that all applicable personnel are trained on new or revised internal procedures
- Pursues and monitors 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 Change Control program
- Assists implementation of quality improvement projects.
- Coordinate department efforts for annual archival of records to offsite storage facility.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
What Makes You Stand Out
- Position requires extensive knowledge of Zimmer Biomet processes, Zimmer Biomet business practices, and Zimmer Biomet business management systems.
- Extensive knowledge of the Quality System Regulation and Associated regulations and standards.
- Individual must be familiar with use of PLM (Product Life Cycle Management) & ERP.
- Requires hands on system and quality system process experience.
- Excellent oral and written skills required.
Your Background
- BA in and engineering or computer science discipline, or
- Bachelor degree in another field with related certifications (e.g. CMM, CQE) plus 5-7 years’ experience in a quality engineering or regulatory compliance role
- One or more years supervising/managing a team is strongly preferred.
Travel Expectations
Up to 10%
EOE
