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Quality Assurance Specialist

1 month ago

Marlborough, Massachusetts, United States Integrated Resources Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Integrated Resources. The successful candidate will be responsible for ensuring the highest quality standards in our Post Market Quality department.

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).
  • Evaluate and investigate complaints to ensure compliance with regulatory requirements.
  • Develop and implement tools to ensure laboratory expenses are met in accordance with the approved budget and forecast.
  • Support the development of budget forecasts and ensure compliance with the approved budget.
  • Implement processes to improve efficiency and ensure compliance with the Post Market Surveillance's requirements.
  • Support Product Transfers and participate in PMS projects.
  • Communicate with OEMs and CMs, as needed, and send the applicable complaint information to the corresponding vendor.
  • Coordinate services with suppliers and availability of the required supplies in house.
  • Ensure equipment is properly calibrated and controlled with the QMS.
  • Execute investigations such as OOTs, NCEs, CAPAs, IACAs, and/or similar.
Requirements
  • University Bachelor's degree in engineering or related career.
  • Strong knowledge of FDA regulations, ISO 13485, ISO 14947, EU MDD/MDR, and related ISO and AAMI standards.
  • Excellent communication and problem-solving skills.
  • Ability to work in a team environment and prioritize tasks effectively.
Preferred Qualifications
  • Experience in a quality assurance or regulatory compliance role.
  • Knowledge of laboratory good practices and test method and procedure development.
  • Statistics and data analysis skills.
Language Requirements

Native English speaker required.

Computer Tools and Knowledge Level Required

Microsoft Office, Internet, Minitab, Oracle, Agile, and H1.