Quality Assurance Engineer

Responsibilities:

• Serve as the primary quality contact for product development projects.
• Ensure product compliance with applicable regulatory requirements.
• Provide guidance on technical processes and documentation to ensure adherence to standards.
• Review and approve product development documentation, including:
  • Product specifications.
  • Verification and validation activities.
  • Risk assessments.
  • Test protocols and reports.
  • Change control documentation.
• Review and approve validation/qualification documentation for equipment and processes.
• Represent quality assurance in product development reviews.
• Provide guidance on problem-solving for technical review activities.
• Collaborate with development teams and other relevant departments.
• Work cross-functionally to provide quality guidance and support project success.
• Support quality system activities, including:
  • Corrective actions.
  • Failure investigations.
  • Non-conformance assessments.
  • Audits.
  • Other assigned duties.

Reporting:

• Reports to the Quality Director.

Qualifications:

• Bachelor’s degree in a technical field (Engineering, Science, or related).
• Minimum 5 years of experience in quality assurance within a regulated industry.
• Demonstrated experience with product development lifecycles, including verification and validation.
• Familiarity with risk management principles and documentation.
• Experience in validation processes for equipment or manufacturing.
• Knowledge of relevant quality standards and regulations.