SERB Pharmaceuticals

Manager

• On site Quality Leadership for medical device production representing all quality oversight
• Quality release of incoming goods and finished medical device products in compliance with ISO 13485, MDSAP, EU MDR, UK MDR, and internal procedures
• Local ownership of the eQMS and DMS systems ensuring compliance with internal procedures and regulatory requirements and standards.
• Quality Assurance approval of GxP documentation such as SOPs and forms and updating training system to ensure compliance
• Direct quality oversight for site Quality Assurance and Quality Control operations including deviation, CAPA, Document Control, Change Control, and Product Testing
• Coordinate Quality Control testing of in-coming goods with supply chain and production to ensure on-time delivery of products
• Review and Quality Assurance approval of compliance documentation such as change controls, CAPA, quality events, change controls, validation protocols and reports.
• Receipt and quality investigation of customer complaints with interface as company representative to customers as required
• Prepare trend reports for quality metrics and report to upper management and identify and escalate quality trends as appropriate
• Identify areas for improvement in compliance and support improvement projects within the business
• Hiring of quality personnel and approval of timecards and PTO
• Management of employee(s) with various levels of experience and ensure employee development
• Alignment of the local quality system with global policies and processes
• Represent Quality Assurance and Quality Control during notified body and government agency inspections and support of activities to correct identified nonconformities

Quality Manager