Website Minerva
The Minerva Endometrial Ablation System is a one-time treatment to help you take control of your heavy periods.
The person in this position is a contributing member of the QA team with specific responsibilities who also becomes a champion in ensuring that the operational quality assurance activities are performed in compliance with the quality system.
Duties & Responsibilities:
- Maintenance of the Calibration/PM System – schedule, review records, and track/close Out of Tolerance Events
- Maintenance of the Environmental Monitoring System – schedule, review records, and track/close Environmental Excursions
- Maintain Finished Goods Release Logs
- Release raw materials – review and approve inspection & test results
- Release subassemblies – review and approve BOM-Routers (DHRs)
- Release sterile loads – review and approve Sterile Lot Records
- Release finished products – review and approve DHRs for capital equipment and single use devices, including refurbished/reworked/repaired product
- Inspection of administrative return goods
- Participate and support internal and external audits and inspections
- MRB System – Track NCR status
- Trending of Quality Data – update quality metrics charts
- CAPA System – track status of requests for correction and corrective and preventive action
- Write/update quality management system documentation as needed
- Review ECOs to ensure complete
- Complete projects in a timely manner and consistence with corporate objectives
Position Requirements:
- Proficient in use of MS Office products such as Word, Excel, is required. Knowledge of Power point and Visio helpful.
- Ability to work well under pressure, to handle multiple projects, and to meet aggressive deadlines.
- Ability to read and understand regulations, standards and procedures.
Preferred Requirements:
- 5+ years in quality assurance/control experience with sterile medical devices and capital equipment. Preferable experience with US Class III medical devices.
- Working knowledge of EN/ISO 13485:2016, US 21CFR 820. Helpful if have knowledge of MDD (2007/47/EC) and Canadian Medical Device Regulations.
- High level of attention to details skills.
- High level of organization skills.
- Effective verbal and written communication skills.
Education:
- Associate degree minimum. ASQ Certification (e.g. Improvement Associate) helpful.