Quality Assurance and Regulatory Affairs Specialist

About the role

• The position supports EMED’s Quality Management System and ensures compliance of the quality/business systems to applicable regulations, standards, and corporate policies.
• This position reports directly to the Director of CA/QA/RA.

What you'll do

• Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
• Administration of Document Control function, including document ID issuance, revision control, coordination of review and approval, communication of implementation tasks, and maintenance of all records.
• Lead/assist with Corrective and Preventative Action (CAPA) investigations, plan development and implementation of corrective actions, author CAPA reports, and ensure completion and accuracy of all associated Quality records.
• Support nonconforming product handling and disposition assessments and manage all records.
• Coordinate the efficient handling and resolution of Customer Complaints, working with contract manufacturer sites and other EMED departments, and manage all records.
• Perform reporting and trending on Quality metrics to ensure an oversight of the compliance landscape for the site.
• Support external audits/inspections with audit readiness preparations, back-room support and response writing to non-conformances.
• May serve as an Internal/Supplier Auditor and conduct audits per schedule
• Write new and revise existing QMS standard operating procedures as directed.
• Review, approve, and maintain device history record files.
• Identify, initiate, and lead process and compliance improvement as requested.
• Interface with other EMED departments such as Engineering, Operations, Customer Service, and Regulatory Affairs as necessary to ensure success for assigned responsibilities.
• Support various Quality Assurance activities as assigned under minimal supervision/instruction.
• Assist with Regulatory Affairs tasks as assigned
• Ensure that all Quality Assurance related tasks and responsibilities defined in EMED Quality Management System Documentation are performed, as defined.

Qualifications

• Bachelor’s degree with desired areas including Science, Engineering or related field.
• Minimum of 3 years of experience in Quality Assurance in pharmaceutical and/or medical device industries.
• Knowledge of MS Office Suite (Excel, Word, Outlook)
• Excellent interpersonal skills, ability to meet deadlines, manage priorities and work well under pressure.
• Ability to work in a self-directed manner and confidently deal with ambiguous issues to drive towards suitable actions.