Requisition Number AMER29128
Employment Type Full-time
Location Norfolk, Virginia
Job Summary
Zimmer Biomet is a global medical technology leader.
Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.
Under minimal supervision, maintains Device Master Record and Device History Records as part of the quality system, and maintains department databases.
Principal Duties and Responsibilities
Creation of Device Master Records such as routers, master cross references, and bill of materials within the ERP system.
Maintain Device Master Records and Device History Records as well as other quality system documents such as training records, monitoring records, authorized signature lists, etc.
Assist with new part number assignment process by creating new part numbers within ERP system for design teams and Marketing department.
Assist with leading weekly change control meetings and processing of all change orders within the quality system.
Handle distribution of all change orders (engineering, specification, and labeling) to appropriate departments.
Assist with the maintenance of the company intranet, Livelink/SAP web based software to ensure the most current document revisions are available at all points of use.
Assist with processing Instructions for Use and all labeling intended for domestic and international distribution.
This includes approval of product labeling using the label producer software.
Maintenance of various databases to ensure compliance to regulations such as indices used for procedures, drawings etc.
Assist with preparing and organizing documents for offsite storage archival and/or archival onto CD.
Maintain storage logs.
Process and distribute various document requests to departments as needed.
Complete various projects as assigned by the supervisor in addition to general filing and copying.
Expected Areas of Competence
Ability to objectively deal with individuals using appropriate tact and diplomacy to establish and maintain a congenial relationship.
Good verbal and written communication skills.
Good word processing and database skills.
Outstanding organizational skills and high attention to detail.
Knowledge of current Food and Drug Administration (FDA) laws, regulations and practices a plus.
Education/Experience Requirements
High School education or equivalent plus one to two years previous regulatory/quality or related experience and six months on-the-job training, or an equivalent combination of education and experience.
Travel Requirements
Minimal
Additional Information
At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together.
We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world.
This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.
EOE/M/W/Vet/Disability
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