Senior Quality Assurance Specialist
Lima Corporate isa global medical device company providing reconstructive and custom-made Orthopedic solutions to surgeons who face the challenges of improving their patients quality of life. For our US branch, we are currently looking for a dynamic and passionateSenior Quality Assurance Specialist.
Reporting directly to the Sr. Regulatory and Quality Manager, the role implements company and regulatory quality standards for product manufacturing. Knowledgeable of industry and governmental quality regulations. The QA Specialist Senior audits and reviews quality data according to existing procedures. Documents results in required format. Develops policies and procedures for records/data management system. Sets up and maintains records/data management system to capture all records control requirements. Work is generally independent and collaborative in nature. Contributes to moderately complex aspects of a project. Position reports to the Sr. Regulatory and Quality Manager.
- Manage the Lima-USA Quality System
- Ensure that the facilitys Quality System is established and maintained in compliance with
- applicable local ordinances, State statues, and Federal regulations, and other laws, including Title 21 CFR 820 Regulations
- Maintain compliance with FDA 21 CFR Part 820 Quality System Regulation
- Ensure proper management of QMS and record retentions
- Support internal audit (planning and organization with QA Team)
- Alert Sr. RAQA Manager of deviations
- Support anomaly, NCR, and CAPA activities and that timelines are being maintained
- Interface regularly with local and LimaCorporate Quality Systems, Process Engineering, Operations, Customer Service, Logistics, Human Resources, and LimaCorporate executive staff
- Create, update, and/or review QMS documents in collaboration with the process owners/SMEs and alerts Lima USA of changes
- Work with HR to ensure that training requirements and records per FDA requirements are being maintained
- Maintain Dashboards and KPIs
- Support in Regulatory inspections
- Support constant process improvements and preventative actions
- Support and/or lead special projects
- Bachelors degree from an accredited college in a related discipline (business management, life sciences, analytics or industrial science), or equivalent experience/combined education, with 7 years of professional experienceor 4+ years of professional experience with a related Masters degree. Considered career, or journey, level.
- Professional Quality discipline certifications (CQM, CQE, CQA, or RAB) desired
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
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