Quality Manager
Hattiesburg, Mississippi, United States of America
Full Time
1 hour ago
No H1B
Key skills
Leadership
About this role
Role Overview
- 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
Requirements
- Bachelor’s degree in life science, pharmacy, chemistry, engineering or related discipline
- Relevant experience of minimum 5 years in Quality for pharmaceutical or medical device manufacturing
- Experience as a supervisor or manager
- Experience in eQMS systems preferred
- Experience participating in GMP audits
- Leadership and motivational skills
- Root cause analysis and risk assessment
- Self-motivated and results oriented driven
Benefits
- Vacation, Personal and Sick time
- 15 Paid Company Holidays
- Medical, Dental, Vision and other Voluntary benefits
- Paid Parental Leave
- Tuition Assistance
- Discretionary Bonus Plan
- Competitive 401(k), $1 for $1 up to 6% of pay. The safe harbour match is vested immediately. In addition, SERB also offers a discretionary match of up to 4% of pay which vests 20% a year for 5 years.