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Quality Engineer

Quality Engineer

Katalyst HealthCares & Life SciencesWorcester, MA
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Job Description :

  • The Quality Engineer is responsible for providing quality assurance support for some or all the following manufacturing processes : pharmaceutical products, medical devices, combination products and biologics.
  • This role will support the strategic direction to ensure business objectives are met.
  • Specific areas of support may include the Product QA, Manufacturing QA, Supplier / Incoming QA, Process Qualification / Validation, Compendia management and CAPA.
  • This position will ensure that all product, process, or system related quality activities from raw material inspection through shipment of final product are following local, Corporate, and governmental regulations.
  • Focus on process qualification PPQ support and review activities on range of topics from process controls to raw material controls.

Responsibilities :

  • Ensure proper integration and support of quality regulations : drug, biologics, device and / or combination products.
  • Assist project teams in planning, preparation, review and approval of quality documentation.
  • Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and / or combination products including compliance with corporate policies, processes and procedures.
  • Apply effective quality systems, procedures and / or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system.
  • May be required to prepare and present data during regulatory audits (FDA, EMA, Anisa, etc) and internal audits.
  • Support the interrelated function activities including design control with R&D, Manufacturing Science and Technology (MS&T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
  • Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
  • Support new product introduction for pharmaceutical products, medical devices, or combination products.
  • Support design changes to existing medical devices and combination products. Interact with internal and external partners for development of best practices in our quality systems and procedures.
  • Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
  • Oversee the implementation and management of training and education programs for various aspects of quality assurance.
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    Quality Engineer • Worcester, MA