Quality Assurance Engineer or Associate

Position Overview

The Medical Device Quality Assurance (QA) Engineer or Associate will ensure compliance with regulatory standards, maintain quality management systems (QMS), and oversee processes to guarantee the safety, reliability, and efficacy of medical devices. This position requires strong attention to detail and knowledge of industry regulations such as FDA 21 CFR 820 and ISO 13485. Responsible for developing, implementing, and documenting medical device quality controls.

Key Responsibilities

  • Quality Management System (QMS): Implement, maintain, and improve QMS in compliance with ISO 13485 and other relevant standards.

  • Regulatory Compliance: Ensure adherence to FDA, EU MDR, and other applicable regulations for medical devices.

  • Documentation: Write, review, and maintain Standard Operating Procedures (SOPs), validation protocols, technical files, and quality records.

  • Risk Management: Conduct risk assessments and implement mitigation strategies in line with ISO 14971.

  • Audits: Assist in internal audits, vendor audits, and FDA/Notified Body inspections.

  • Post-Market Surveillance: Monitor device performance through post-market studies and manage customer complaints or non-conformance investigations.

  • Validation & Verification: Oversee testing activities to ensure product design meets intended use and specifications.

Qualifications

  • Bachelor’s degree in Health Sciences, Engineering, or related field.

  • Minimum 2 years of experience in medical device QA or a regulated environment.

  • Familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820, and EU MDR requirements.

  • Strong organizational and communication skills with attention to detail.

Preferred Skills

  • Experience with QSR and CE marking processes.

  • Proficiency in scientific writing and technical documentation.

• This role offers flexibility for professionals seeking a part-time position while contributing to the development of safe and effective medical devices.