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Quality Systems Manager

Mountain Lakes, New Jersey

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Responsibilities

Location Mountain Lakes, New JerseyUS Job ID JR-026957

Responsibilities:

In this position, the incumbent will,

  • Serve as a Deputy Designee for a Management Representative for notified body for ISO certification.
  • Serve as a liaison between the company, notified body and various governmental agencies
  • Mitigate risks through establishing various control and other risk management activities as appropriate.
  • Manage and control quality system documents, update and revise as necessary.
  • Provide quality system training of employees; provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to ensure compliance.  
  • Identify key processes, oversee and monitor the validation & qualification activities.
  • Work directly with production, quality control departments to ensure that cGMP, sampling, qualification, and statistical process control analyses requirements are met on a continuing basis as required.  
  • Work directly with IT staff and other department heads to advise and oversee the software qualification activities.
  • Establish, manage and oversee purchasing controls activities such as supplier management to ensure quality products are purchased and used throughout the quality system.
  • Work directly with receiving and quality control departments to ensure that the raw materials, components, finished kits, instruments and other materials received are qualified as appropriate before its use.
  • Ensure that non-conforming products are identified, segregated and disposed of properly and as appropriate.
  • Ensure rework (if any) is performed by following appropriate procedures and their documentation.
  • Ensure that the customer notifications are issued and released as appropriate.
  • Work directly with technical support and other departments to review customer complaints & feedbacks to ensure that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction
  • Manage and perform internal quality system audits, issue CAPA, monitor its effectiveness and their documentation.
  • Lead in external quality system audits, respond to any CAPA and provide resolution.
  • Drive the development of metrics (KPI) for all areas of the quality system, analyze quality data and report metric results at Management Reviews; lead continuous improvement activities.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Basic Qualifications:

  • Bachelor’s degree in Life Sciences or STEM discipline
  • 5 years of quality experience
  • 3 years of experience in a management or lead role in a regulated medical device or diagnostic laboratory environment.

OR

  • Master’s degree in Life Sciences or STEM discipline
  • 4 years of quality experience
  • 3 years or experience in a management or lead role in a regulated medical device or diagnostic laboratory environment.

Preferred Qualifications:

  • Excellent understanding of principles of quality management systems.
  • Leading external/internal audits, CAPA resolution; and writing technical documents
  • Managing people, processes, and department
  • Implementing software solutions as needed for various processes

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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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