Quality Engineer

Katalyst Healthcares & Life Sciences
Burlington, MA
Closing date
Jul 1, 2022

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Job Description Responsibilities:
  • Manages the CAPAs, Change Controls, Internal and External Audit programs and maintain associated tracking logs. Has capability to manage these programs within the Electronic Quality Management system upon implementation.
  • Evaluates and improve the above programs to ensure compliance with regulatory requirements.
  • Performs internal and external audits as assigned and track implementation of audits observations for on time closure.
  • Maintains the Approved Supplier List including updating and reviewing vendors performance as assigned.
  • Leads investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions as needed.
  • Performs QA review of new and revised procedures, technical protocols, validations and reports as assigned.
  • Participates as assigned in the development of customer requirements and design inputs; works with team to ensure that customer requirements (user needs) can be validated and design requirements can be verified
  • Facilitates the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process and regulatory requirements
  • Designs and maintains procedures and systems for process and quality data collection
  • Conducts and/or supports process capability evaluations and determines critical process control points and appropriate control limits.
  • Support equipment and process validation methods to ensure they are properly validated prior to implementation and critical equipment is periodically re-validated
  • Conducts gap analyses of in-house practices versus relevant regulations, standards and industry practices; develops plans and implements corrective actions to ensure continued compliance.
  • Act as the SME trainer of other QA personnel.
  • Performs other related duties as assigned
Education & Experience:
  • Requires a Bachelor's Degree in engineering or related discipline with a minimum of 3 to 5 years related experience and demonstrated working knowledge of scientific principles.
  • Prior experience with management of process change controls, CAPAs, Internal/External and Supplier Audits.
  • Strong knowledge of statistical process control methods and techniques.
  • Working knowledge and demonstrated application of ISO 14971 Risk Management for Medical Devices
  • Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices.
  • Knowledge of the FDA 21CFR, EU, TGA (Australia), ANVISA (Brazil)
  • Working knowledge of cGMPs, QSRs, MDDs, MDR
  • Familiarity with the principles of Design Control
  • Working knowledge of Electronic Quality Management System.
  • Working knowledge of Six Sigma a plus
  • Strong writing and presentation skills
: 22-00328 : Bedford, MA:

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