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Quality Assurance Post-Market Engineer

Location: Chelmsford, MA

Resuscitation

Job Summary:

The individual will support Post-Market activities in the areas of improvement, customer facing, and project related work. Responsible for supporting improving the effectiveness and efficiency of the overall post-market process. Lead risk management related activities for existing devices and support post-market quality by assisting with analysis and investigation of product or quality system issues.

Essential Functions:

  • Maintain knowledge base on new regulations and standards that affect Complaint Handling and Risk Management for medical devices.
  • Provide outstanding customer support with investigation updates and customer communication when required.
  • Take an active role in leading improvement projects with respect to the creation of tools to aid in the FDA, Health Canada, Vigilance reporting and registrar reporting for ISO 13485.
  • Coordinate business meetings to communicate and align the organization on customer related product issues and ensure appropriate decision making is made to initiate actions.
  • Understands and has the ability to perform validations (IQ, OQ, PQ)
  • Provide strategies to regulatory related inquiries including written response(s).
  • Identify opportunities or detections within the process through statistical analysis, critical thought, and development of a clear set of recommendations to the team and management for resolution
  • Collect, analyze, and disseminate quality data throughout the organization
  • Assist in developing proactive communications with Regulatory Authorities worldwide.
  • Meet Departmental, Corporate and Project Objectives in a timely manner in accordance with the ZOLL QMS.
  • Participate in areas such as Corrective and Preventive Action program and Internal/ External audits.

Skill Requirements:

  • Working knowledge of Quality Engineering and medical device regulations (FDA
  • 21CFR 820, 803, ISO13485, and Medical Device Directive)
  • Demonstrated results improving quality within an ISO/FDA manufacturing environment
  • Thorough understanding on how to perform risk analysis including, Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure process shortcomings are identified and appropriately addressed
  • Excellent interpersonal and public speaking communication skills
  • Proficient with Microsoft Office Suite. Access is a plus
  • Excellent business and technical writing a must
  • Must be accountable for achievement of desired results
  • Approximate travel is 20% (international or domestic) including traveling between ZOLL Manufacturing sites

Required/Preferred Education and Experience:

  • Bachelor’s degree with 5-10 years of medical device experience in Quality preferred
  • DMAIC Black Belt Certified or Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) preferred

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

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