Quality Assurance Specialist

Biocoat is a global leader in developing, manufacturing, and applying hydrophilic coatings on medical devices. The company is seeking a Quality Assurance Specialist to join its team.

Requirements

• Review, approve, and document batch records and release of product
• Administration and of all QMS documentation
• Document Control and Training SME and electronic QMS (e.g., Grand Avenue) administrator
• Implement, review, and facilitate investigations including Corrective and Preventive Actions (CAPA)
• Assist with and/or lead investigation and resolution of customer complaints
• Assist in and/or lead the management of change controls/ECOs and associated activities
• Lead Material Review Board meetings and facilitate material and documentation dispositions as needed
• Communicate deficiencies and/or compliance issues to QA/RA management
• Responsible for driving goals and initiatives for continuous improvement of procedures, processes, and systems
• Compile data and report QMS metrics as required
• Administer and deliver Quality Assurance training
• Coordinate and perform audits (internal, process) as required
• Support and organize audit preparation and performance activities
• Support testing and release activities for Quality Control (QC)

Benefits

• Competitive salary, eligible for a discretionary bonus
• Benefits (medical with HSA component, dental, vision, critical illness, and accident insurance)
• Life insurance, short- and long-term disability paid by the company
• Flexible Spending Accounts (FSAs)
• 401(k) plan with an immediate company match
• Paid time off
• Education Assistance Program
• Rewards and Recognition Program
• Parental Leave
• Employee Assistance Program