QA Specialist

Role & responsibilities

• Conducts and/or participates in QA activities that include, but not limited to:
• Audit activities, including planning, conduct, response, and documentation
• Quality issues, complaints, nonconformities and Corrective and Preventive Actions (CAPA)
• Vendor/ supplier qualifications
• Quality management review
• QA and regulatory compliance reviews of documentation
• Periodic review of controlled documentation, and assessments of internal files
• Performs document control activities, including quality record maintenance.
• Performs activities related to personnel training and maintenance of training documentation.
• Involved in administration and overall maintenance of the companys eQMS
• Contributes to development, review, and revision of procedures in accordance with the QMS.
• Assist with regulatory submissions related to the proprietary medical device software.
• Participates in QA-related meetings: scheduling, agenda, minutes, and action item management.
• Provides QA and regulatory compliance guidance and feedback cross-departmentally.
• Reports quality aspects to departmental Lead or Officers as part of management review.
• Performs other departmental activities as needed and upon request.

Preferred candidate profile

• ​​​​​​Requires undergraduate degree and at least 3 years of experience in activities related to quality, or an acceptable combination of education and experience.
• Experience in medical device, pharmaceutical and/or biotech clinical research industry a must.
• Working knowledge of regulations, standards and guidelines related to quality in clinical trials.
• Experience in regulatory submission activities for medical devices preferred.
• Knowledge of eQMS a plus.
• Excellent written and oral communication, attention to detail, organizational and planning skills.
• Ability to perform and maintain quality work while prioritizing and managing multiple deadlines.
• Ability to work with different departmental designees on quality-related activities​.

Perks and benefits

Best In the Industry