QA Specialist

• Support the implementation and ongoing maintenance of the Quality Management System.
• Review and approve batch documentation to ensure compliance with applicable regulatory requirements and quality standards prior to batch release.
• Collaborate with cross-functional teams to maintain GMP and regulatory compliance across operations.
• Review, manage, and maintain Device Master Records, Device History Records and other related quality documentation.
• Participate in investigations and resolution activities related to quality issues, non-conformances, and customer complaints.
• Assist in the development, implementation, and monitoring of Corrective and Preventive Action
• Support internal and external audits, including preparation, execution, response coordination, and follow-up actions.
• Work with cross-functional teams to ensure quality standards are upheld throughout all stages of the product lifecycle.
• Provide Quality Assurance oversight for manufacturing, packaging, labeling, and distribution processes.
• Contribute to the creation, review, and maintenance of Standard Operating Procedures, work instructions, and other controlled documents.
• Maintain quality records and ensure adherence to proper documentation practices.

• Bachelor's or Masters degree in Engineering, Science or related discipline.
• Minimum of 3+ years experience in Quality Assurance roles within the medical device or other regulated sectors
• Quality Management Systems for Medical Devices such as GMP/GDP, ISO and FDA
• Proven experience leading investigations, managing CAPAs, and participating in audits.
• Strong technical writing and communication.
• Excellent analytical and problem-solving abilities.
• High attention to detail.
• Ability to work effectively in cross-functional teams.

Morgan McKinley