Supervisor, Quality Assurance

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 primary function of the Quality Assurance Supervisor is to ensure that all established quality system procedures are in place and executed in meeting the new build and service plans as well as departmental operational metrics. This will involve daily supervision of Quality Assurance Inspection Staff including but not limited to scheduling, training, interviewing, and all other tasks related to employee relations

Duties and responsibilities

  • Execute the build plan to meet field requirements.
  • Execute the service plan to meet field requirements.
  • Execute to meet departmental operational metrics.
  • Direct supervision of quality assurance inspectors.
  • Plan, assign, participate, supervise and review the work and work instructions and identify process improvement opportunities that drive quality and business results (i.​e.​ waste elimination, improving inspection efficiencies, adequate controls, etc.​).​
  • Participate in the selection of inspectors; provide or coordinate training; work with employees to correct deficiencies; implement coaching and performance management; maintain records and prepare reports; ensure quality standards are met.​
  • Ensure that proper inspection procedures are followed.​
  • Work special high priority tasks as assigned.​
  • Anticipate problems and work to mitigate risks.​
  • Performs other duties as assigned by Management.

Qualifications

  • Bachelors or Associates degree in a related field with training in a mechanical or electronics discipline or 5-7 years related work experience
  • Minimum five years of experience as a lead inspector or supervisor in an FDA regulated medical device manufacturing environment.
  • Must have a strong understanding of ISO 13485 and FDA GMPs.
  • Excellent communication and organizational skills.
  • Experience with database queries and reporting in SQL or Microsoft Access preferred. 
  • Lean experience preferred. 

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

Assists the manager in supervising employees within the Quality Assurance Department.  Executes supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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