Senior Quality Assurance Engineer

5 days ago


Billerica, Massachusetts, United States Access Vascular Full time
About the Role

We are seeking an experienced Senior Quality Engineer to join our team at Access Vascular, Inc. This is a full-time position offering a competitive salary of $120,000 - $150,000 per annum.

Job Summary

The Senior Quality Engineer will be responsible for developing, improving, and maintaining AVIs Quality Systems, overseeing quality control operations, and supervising a team of Quality Control technicians.

Duties & Responsibilities
  • Develop and implement Quality Systems that meet FDA QMSR requirements and internal compliance standards.
  • Leverage continuous improvement methodologies to enhance AVIs Quality Systems.
  • Lead or participate in project-related quality activities, including product release and change control.
  • Provide quality oversight, ensuring production and supply chain processes align with applicable regulations, standards, and guidelines.
  • Effectively execute the nonconformance report (NCR) process, including timely investigations.
  • Monitor and publish quality metrics, analyzing data to identify trends and implement preventive measures.
  • Collaborate with Operations and Supply Chain departments to address root causes of quality issues.
  • Supervise work schedules to support manufacturing operations, as needed.
  • Support internal audits and maintain accurate quality control records.
Qualifications
  • Bachelor's degree in a related technical field, preferably Engineering.
  • At least 8 years of Quality Engineering experience in the Life Science or Medical Device Industries.
  • Working knowledge of 21 CFR 820 and ISO 13485 is mandatory.
  • Ability to review and write technical documentation.
  • Self-initiator with strong organizational skills.
  • Teamwork, flexibility, and adaptability to change.
  • Proficient problem-solving skills.


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