Product Quality Specialist
Haemonetics Corp. - Fajardo, PR

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HAEMONETICS, THE Blood Management Company is a global leader engaged in the design, manufacture and worldwide sales and marketing of blood management solutions. Recognized as the innovator in blood technologies, our mission is to create innovative products, design information technology platforms and to provide consulting services to advance the safety, quality and availability of the world’s blood supply.

Product Quality Specialist

Responsible for handling and/or providing support to the investigations of customer complaints and implementation of Corrective/Preventive Action (CAPA) to prevent re-occurrence. Management and reporting for the CAPA system. Support Process / Laboratory validation protocols. Responsible for performing trending to monitor internal and external product quality issues. Receive, log, classify, distribute and file applicable samples and documentation generated from the Quality area. Trainer in Quality disciplines as required.

• Generates and monitors internal and external product quality trend metrics and goals.
• Manage the CAPA systems for the Site and create reports CAPA in a timely manner. Conduct periodic CAPA meetings and/or reviews.
• Responsible for handling investigations of customer complaints and implementing Corrective/Preventive Action (CAPA) to prevent re-occurrence.
• Provide support during the resolution of product quality internal issues.
• Complies with Internal / External audits inspections by preparing documentation for inspection/testing procedures and participating in Supplier / Internal audits as required.
• Supports validation process by developing and execution of qualification protocols reports, validation plans, and FMEAS for process or laboratory areas.
• Receive, log, classify, distribute and file applicable samples.
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
• Manage the record retention for the applicable information such as Validation protocols, Risk Management, Corrective Action Plans, Equipment Manuals and Engineering Studies.
• Manage first lot notification database.
• Perform review of the MMRR and DHR as needed.
• Trainer in Quality disciplines as required.
• Contributes to team effort by accomplishing related results as needed.
• Complies with QSR, ISO and all applicable regulations and company procedures.
• Acknowledge and maintain commitment with the environmental policy, and participate actively in the environmental programs to achieve the objectives and targets with their area.
• Participate in the development of environmental improvement projects, which imply the minimization, all possible negative environmental impacts of daily operations and activities.

Education and Experience Requirements:

• Bachelor Degree in Science with Major in Biology, Microbiology or Chemistry.
• Zero (0) to two (2) years of related experience in Medical Device or Pharmaceutical industry preferably.

Haemonetics Corporation is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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