Zimmer Biomet

Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!

What You Can Expect

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; and coordinate department efforts for annual archival of records to offsite storage facility.

How You'll Create Impact

What Makes You Stand Out

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.

Your Background

• Requires a Bachelor's in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Pharmaceutical Sciences, or related field.

Travel Expectations

• Role permits remote work throughout the U.S. Role requires up to 10% domestic travel.
• 40 hours per week, Monday through Friday, 8:30 AM to 5:00 PM

Zimmer, Inc., 56 E Bell Drive, Warsaw, IN 46582

EOE/M/F/Vet/Disability