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Manager, Quality Assurance Quality Control

Location: Pawtucket, RI

Resuscitation

Develop, implement and manage quality control program designed to ensure continuous production of electrodes consistent with established standards, customer specifications and production goals. Supervise a team of Final QC Inspectors.

Essential Functions:

  • Provide technical guidance to QC personnel.
  • Supervise personnel engaged in final inspection and testing activities.
  • Act as the Management Representative Designee within the Bio-Detek’s Quality system.
  • Ensure a high level of internal and external customer service.
  • Investigate (and correct) customer issues and complaints relating to quality.
  • Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection.
  • Create, document and implement inspection criteria and procedures.
  • Provide and oversee inspection activity for product throughout production cycle.
  • Collect, analyze and disseminate quality data throughout the organization.
  • Design, develop and implement quality control training programs.
  • Participate in Material Review Board activities.
  • Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements.
  • Provide support and participate in customer and agency quality audits.
  • Develop and implement quality improvement programs
  • Lead departmental effort in CAPA investigation and completion
  • Maintain the Calibration program
  • Participate in validation and verification planning activities, including protocol and report review
  • Participate in Engineering Change Order review and approval activities as required
  • Other duties as assigned

Competencies:

  • Minimum 5-10 years related experience in a regulated environment,  preferably medical device, 5 years in managerial/supervisory role
  • Proficient at problem solving – analytical and diagnostic proficiencies
  • Strong communications skills to include presentation capabilities
  • Excellent verbal & written communication skills.
  • Experience with ISO 13485 and FDA QSR for Medical Devices and FDA Quality System Requirements

Education:

  • Four year degree in technical or science discipline

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job.  Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity.  Essential and marginal job functions are subject to modification.

ZOLL Medical Corporation appreciates and values diversity.  We are an Equal Opportunity Employer M/F/D/V. 

ADA:  The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990