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Manager of 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.

Position Summary:  This position will be responsible for managing a staff of 25+ quality assurance inspectors and quality engineers in a Class 3 PMA medical device manufacturing company.  An in-depth knowledge of FDA’s Quality System Regulation and ISO 13485 Quality Management System is required.  Areas of responsibility include, but are not limited to, the CAPA program, internal and external quality audits, and the nonconforming material process.  The Manager will ensure sufficient staffing and resources are available to achieve business goals and compliance requirements.  This position is also responsible for the creation and maintenance of written inspection instructions, performing trend analysis on various quality data, and presenting the reports to management.

Essential Duties and Responsibilities:

  • Manages and maintains the inspection and product release programs for incoming and in-process materials and finished goods. 
  • Responsible for data collection and performance analysis of various quality metrics.
  • Responsible for supplier qualifications and supplier quality performance.
  • Liaise with external inspectors/auditors.
  • Responsible for monitoring QA processes and meeting production and department schedules (including audit, and calibration).
  • Manages the Quality Engineering and Inspection Departments. 
  • Performs other duties as assigned by Management.

Supervisory Responsibilities: Directly supervises employees in the Quality Assurance Department. Carries out 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.

Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skills and abilities required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.

Educations and/or Experience:

  • 4 year degree in a scientific or technical discipline or equivalent experience (minimum 5 years in area of discipline).
  • Requires a minimum of four years of experience as a quality assurance engineer in a medical device manufacturing environment. 
  • Requires in depth knowledge of 21 CFR 820 and ISO 13485 quality system requirements. 
  • Management experience preferred. 

Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.  Ability to write routine reports and correspondence.  Ability to speak effectively before groups of customers or employees of organization.

Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.  Ability to apply concepts of basic algebra and geometry.

Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems involving several concrete variables in standardized situations.

Physical Demands:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 25 pounds.

Work Environment:

  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • The noise level in the work environment is usually quiet.

 

ZOLL is an Equal Opportunity Employer.

 

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