Product Quality Assurance Engineer

Location: Pittsburgh, PA

Cardiac Management Solutions

The Cardiac Management Solutions division of ZOLL Medical Corporation develops products to protect and manage cardiac patients, including the LifeVest® wearable cardioverter defibrillator (WCD), the ZOLL cardiac monitor, and associated technologies.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need. To date, the LifeVest WCD has been worn by hundreds of thousands of patients and saved thousands of lives.

ZOLL has been Pittsburgh’s Manufacturer of the Year, one of Western PA’s Healthiest Employers, and even one of Pittsburgh’s Coolest Offices. But it’s our unique opportunity to impact people’s lives that makes ZOLL the ideal place to build your career.

Job purpose

The Product Quality Assurance function supports the delivery of high-quality medical products by providing personnel at all levels with appropriate visibility into, and feedback on, associated products throughout the Product Lifecycle, however mostly focused on finished product. The practices in Product Quality Assurance area ensure that planned processes are implemented, while the practices in the verification process ensure that specified requirements are satisfied.

Duties and responsibilities

  • Own ongoing product quality testing (the proactive search for product quality issues before they manifest in the field)
  • Be responsible for working with the relevant departments to resolve all issues related to quality and reliability
  • Identify, document and report on noncompliance issues. Provide feedback to project staff and managers on the results of product quality assurance activities
  • Ensuring that noncompliance issues are addressed via CAPA and facilitate root cause analysis and CAPA response as necessary.
  • Coordinate failure analysis activities with internal and external 3rd parties as needed.
  • Monitor and analyze production, field, and customer complaint data to identify product quality issues.  Develop new data and analysis processes as needed.
  • Process feedback to organization to ensure that objective evaluations are perceived to have value and are efficient, Define (1) how objective evaluations are to be done, (2) which processes and work products will be evaluated, (3) how results of evaluations will be integrated into the team’s rhythms (e.g., as part of daily meetings, checklists, peer reviews, tools, continuous integration, retrospectives)
  • Continual improvement of product requires the product quality engineer to be hands on with the R&D, Engineering and Production teams

Qualifications

  • Bachelor’s degree in a related field with training in a mechanical or electronics discipline or 5-7 years related work experience
  • Typically 3 years or more of successful experience in Product Quality Engineering or Reliability Engineering, and successful demonstration of Key Responsibilities and Knowledge as presented above.
  • Minimum 3 years of experience in an FDA regulated medical device manufacturing environment.
  • Must have a strong understanding of ISO 13485 and FDA GMPs.
  • Excellent communication (oral and written) and organizational skills.
  • Methodologies - Reliability Analysis, Risk Management, 8D / Root Cause Analysis reports, presentation techniques, facilitation, FMEA, risk analysis, field quality analytics.
  • Lean Six Sigma experience, experience with GD&T and FMEA Moderator preferred. 
  • American Society of Quality Certified Reliability Engineer, Certified Quality Engineer a plus.

Working conditions

This position is generally performed in a typical office environment that is usually quiet.  Employee is expected to work collaboratively with team members, as well as able to work independently with limited supervision.  Work will require significant computer and telephone work.

Physical requirements

While performing the duties of this Job, the employee is regularly required to sit, talk and hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

Supervisory responsibility

This position will not have direct oversight or supervision responsibilities. Position may have process ownership and require aligning and holding resources accountable for results.

AAP/EEO Statement

ZOLL is committed to fostering an inclusive workplace, where unique identities, backgrounds, cultures, perspectives and experiences are respected and valued.

 Equal Opportunity Employer – Disability and Veteran

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