Quality Assurance Specialist

1 day ago

Marlborough, Massachusetts, United States Integrated Resources Full time
Job Title: Quality Assurance Specialist

Integrated Resources is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services.

Key Responsibilities:
  • Assess complaints and assign the applicable complaint failure mode and determine if escalation is required if the event is related to a Potential Adverse Event (PAE).
  • Escalate events to the Clinical Specialists and/or PMS Manager when there is any Potential Adverse Event described.
  • Testing of returned units from reported complaints.
  • Ensure complaint investigation procedures are best in class and aligned with the requirements.
  • Closing complaints in a timely manner.
  • Ensuring KPIs are met in accordance with the established goals.
  • Review and approve complaint investigations in the QMS, as required.
  • Providing input to the organization regarding the information gathered from complaint investigations.
  • Supporting preparation of budget forecasts and ensuring compliance with the approved budget.
  • Implementing tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
  • Innovating processes to improve efficiency and ensure compliance with the Post Market Surveillance's requirements.
  • Supporting Product Transfers.
  • Participating, supporting, and/or leading PMS projects.
  • Supporting and promoting the implementation of EHS programs to ensure staff safety and environmental health.
  • Communicating with OEMs and CMs, as needed, and sending the applicable complaint information to the corresponding vendor.
  • Coordinating services with suppliers and availability of the required supplies in house (as applicable).
  • Coordinating and ensuring that required payments to vendors are performed on time.
  • Making decisions following a risk-based approach, implementing tools as FMEA, Fault Tree Analysis (FTA), and risk evaluation.
  • Supporting other facilities and OEMs/CMs, as required.
  • Ensuring equipment is properly calibrated and controlled with the QMS. Ensuring the Preventive Maintenance program is implemented as required.
  • Executing investigations such as OOTs, NCEs, CAPAs, IACAs, and/or similar. Ensuring they are performed on time, in compliance with procedures and regulations.
Requirements:
  • Drive for Results
  • Planning
  • Organizational Agility
  • Listening
  • Decision making
  • Problem Solving
  • Communication
Education:
  • University Bachelor's degree in engineering, or related career.
Specialized Knowledge (Desirable):
  • FDA regulations (Including the MDR for Manufacturers Guidance), ISO 13485, ISO 14947, EU MDD/MDR, and any related ISO and AAMI standards.
  • Equipment qualification.
  • Laboratory good practices.
  • Test method and procedure development.
  • Statistics.
Language:
  • Native English.
Computer Tools and Knowledge Level Required (Desirable):
  • Microsoft Office, Internet, Minitab, Oracle, Agile, and H1.

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