16 days old
2018-04-102018-05-09

Quality Associate Manager (604847)

Zimmer Dental, Inc.
Palm Beach Gardens, FL
  • Job Code
    88594

Job Summary





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.



Principal Duties and Responsibilities





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.



Expected Areas of Competence





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.



Education/Experience Requirements





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 Requirements





Up to 10%



Additional Information





EOE/M/W/Vet/Disability







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Quality Associate Manager (604847)

Zimmer Dental, Inc.
Palm Beach Gardens, FL

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Zimmer Dental, Inc.
Palm Beach Gardens, FL
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