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Line Quality 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.

Position Summary: The Line Quality Engineer is a member of a support team for the manufacturing and/or service lines.  This position coordinates actions with the Production Supervisor and Manufacturing Engineer to drive attainment of key performance indicators and Operations Excellence plans.  This role serves as the team’s subject matter expert on issues related to the organization’s Quality System.

Essential Duties and Responsibilities:

  • Coordinates daily action-plan with the Production Supervisor and Manufacturing Engineer to meet KPI goals.
    Supports the new build and/or service production lines by planning, coordinating and executing actions to drive Operations Excellence based upon Future State Value Stream Map, and the OpEx maturity model.
  • Develops and assesses standard work for the production and/or service lines.
  • Understands FDA’s QSR 21CFR820.
  • Performs a variety of complex tasks related to Quality Assurance including, but not limited to:  performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities. 
  • Participates in the nonconforming material/Material Review Board process.
  • Performs internal quality audits and effectiveness reviews (FDA’s QSR, ISO 13485, MDD, CMDR) as assigned.
  • Conducts various risk analysis activities for new and existing products including process FMEAs. 
  • Participate in production pilot runs for process changes or product launches.
  • Address internal audit findings based on functional area
  • Champions change orders related to the production/service lines.
  • Performs other duties as assigned by Management.

Supervisory Responsibilities:  None.

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:

  • Requires a minimum BS degree in an engineering discipline.
  • Requires a minimum three years of experience in an ISO 13485 registered electro-mechanical medical device manufacturing facility.
  • Proficient with Microsoft Office applications.
  • Requires a minimum of three years of experience in an FDA regulated Class III electrical medical device manufacturing environment.
  • Requires a minimum of three years of hands-on lean experience. 
  • A minimum Six Sigma Green Belt is required (Black Belt preferred).
  • ASQ certification preferred.

Language Skills:  Ability to read and comprehend simple instructions, short correspondence, and memos.  Ability to write simple correspondence.  Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

Mathematical Skills:  Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. 

Reasoning Ability:  Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.  Ability to deal with problems and make appropriate judgment calls to insure the correct outcome.

Computer Skills:  To perform this job successfully, an individual should be proficient in Microsoft Office Suite.

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 frequently required to sit, walk, talk and hear.  Employee may occasionally be required to lift and carry 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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