Quality Manager (679738)
Zimmer Biomet

Jersey City, New Jersey

Posted in IT
11 days ago

This job has expired.

Job Info

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. 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.

Provides technical and administrative guidance to Quality Assurance, Manufacturing, and suppliers of raw materials or finished medical devices. Assures product conformance to established requirements and standards through appropriate inspection and test activities. Coordinates quality planning, inspection method development and defect prevention/corrective action processes for new and existing products. Identifies and solves product and process problems and supports various operational groups. Assists in the preparation and monitoring of the operating and capital budgets.

Principal Duties and Responsibilities
  • Determine and define quality assurance requirements from review of engineering drawings and/or specifications, industry standards, government specifications or other applicable source documents.
  • Establish and coordinate management of overall site Quality System requirements and regulatory compliance activities including Internal & External Audit management.
  • Maintain oversight of product acceptance activities for manufactured and purchased goods.
  • Formulate, write and maintain procedures, specifications and standards for the quality control of Zimmer products including non-destructive testing methods, gauge design and procurement, sampling and inspection methods and visual acceptance standards.
  • Coordinate the maintenance of the environmental, monitoring, and calibration program for all inspection tools and gauges to comply with division and corporate Good Manufacturing Practices.
  • Develop and administer effective data collection and reporting system to meet regulatory requirements and management information needs.
  • Manage overall control including processing, delivery, and disposition of nonconforming products until deficiency or unsatisfactory condition has been corrected.
  • Coordinate local corrective and preventive actions along with support and review of process validation and equipment qualification activities.
  • Provides resources, including the assignment of trained personnel for performance of work and assessment activities to meet requirements.
  • Implement defect prevention strategies utilizing SPC/SQC principles and practices.
  • Partner with other functional areas like Operations, Engineering, Regulatory, Finance, etc. and manage the functional budget.
Expected Areas of Competence
  • Lead and motivate team members through feedback and stretch assignments.
  • Establishes and maintains high levels of credibility.
  • Collaborates effectively across the organization, leverages resources from other parts of the organization to build commitment and achieve results.
  • Interpret engineering drawings and specifications.
  • Teamwork and customer focus oriented.
  • Demonstrate ability in selecting, interviewing, training, coaching, motivate, discipline, and direct people.
  • Must possess good analytical and writing skills and be familiar with both the scientific and vernacular vocabularies.
  • Communicate effectively with both production/inspection workers and senior management
  • Good knowledge of applicable government specifications, standards and regulations such as Quality System Regulation and ISO standards.
Education/Experience Requirements
  • This position requires a Bachelor's Degree preferably in engineering or a related discipline with 6+ years of work experience in quality functions
  • Or an advanced degree (ex. Masters) in a related discipline with 4+ years experience.
  • Quality discipline certification preferred (e.g., CQA, CQE, CQM, etc.).
  • Must be experienced in all aspects of modern quality control methods such as nondestructive testing, metrology, statistical process control, quality cost accounting, applied statistics and inspection.
  • Experience in dealing with representatives from Food and Drug Administration or other regulatory agencies.
  • Quality Engineering Certification (ASQ) a plus.
Travel Requirements
  • Up to 10%
Additional Information

EOE M/W/Vet/Disability.

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.

This job has expired.

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