Working for an incredible growing MedTech company with life-saving products in Medical Devices. This company have novel devices that have a massive impact on patients and they are set to experience continued explosive growth over the coming years. They are a stable company with good investment and are looking to add a crucial member to their Quality Organisation.
This role is a Quality Engineer position.
Job Role and Responsibilities:
- Manage and Maintainance of the Quality Management System (QMS)
- Assist in Internal audits on systems and documentation
- Adhere to QMS requirements outlined in procedures and work instructions
- Write, update and/or review SOPs and QA technical data forms and quality documents
- Authors nonconformance reports and CAPAs
- Review validation protocols for GMP compliance
- Performs investigations of non-conformances, customer complaints and corrective actions
- Prepares quality metrics and presents to management
- Assists with contract manufacturer engineering change orders (ECO)
- Ensures follow up and resolution of identified or assigned quality issues
- Taking the lead as the Design Control Coordinator: works with product development engineering to ensure proper completion of required documentation for design control phases according to the design controls Standards of Practice (SOPs).
- Audits suppliers, systems, and documents to assure quality assurance compliance with all internal procedures as well as regulatory guidelines.
- Maintains and demonstrates an understanding of global standards, regulations, and regulatory bodies to include but not limited to ISO 13485:2016, 21 CFR part 820, 21 CFR part 812, MDSAP and MDR
- 2+ years experience in Quality Assurance in Medical Devices (e.g., ISO 13485:2016, 21 CFR Part 820 and MDSAP) in a Quality Engineering or Design Control position
- Strong experience and understanding of Design Controls
- Bachelor of Science in Engineering or Life Science Field
- Working knowledge of standards and regulations as outlined in the QMS documentation and structure
- ISO 13485:2016 auditor preferred