Quality Assurance Manager - 29944BR - EN in Allendale, NJ at Stryker Corporation

Date Posted: 5/12/2018

Job Snapshot

Job Description

As a Quality Assurance Manager you will establish a quality center of excellence, develop organizational strategies, processes, goals, and metrics to drive measurable improvements in quality processes. Oversee the consistency of quality processes. Manage and address potential product and safety investigations through investigation and corrective action.
  • Lead team of Quality Engineers in support of New Product Introduction.
  • Perform performance management and facilitate professional development for direct reports.
  • Responsible for Calibration and Validation program at Allendale facility.
  • Develop strategic plans for resource deployment and process improvement.
  • Manage day-to-day quality processes to ensure issues are appropriately evaluated.
  • Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.
  • Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met.
  • Serve as Subject Matter Expert for quality processes.
  • Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
  • Establish standard process to ensure appropriate resolution and management of the responsible task owner.
  • Chair meetings required to drive closure of quality issues.
  • Manage and provide updates for quality metrics. Implement appropriate enhancements.
  • Represent quality processes during internal and external audits.

Job Requirements

  • Master's Degree or equivalent preferred.
  • Minimum of 9 years’ experience preferred.
  • Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.
  • Demonstrate technical knowledge of medical device product lines.
  • Demonstrated written, verbal, listening, communication, and team-building skills.
  • Demonstrated ability to collaborate effectively with and lead cross-functional teams.
  • Demonstrated ability to effectively prioritize and manage multiple project workloads.
  • Demonstrated experience with trending and analysis reporting.
  • Demonstrated knowledge of adverse event reporting, complaint investigation, CAPA, and corrective action processes.
  • Demonstrated leadership skills.
  • Demonstrated process improvement and management skills.

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