- Instituting, monitoring, and updating the Quality System at the division for compliance with FDA QSR, cGMP, and ISO 13485 requirements.
- Ensuring that Standard Operating Procedures and other controlled documents go through periodic review within the electronic document management system, and that training as required by management, is recorded and accounted for.
- Ensure the Internal Quality Audit schedule is established yearly, that audits occur as scheduled, and that the audit records and any corrective actions are maintained and reviewed.
- Establishing and preparing for bi-annual Quality System Management Review meetings and ensuring appropriate areas are represented.
- Instituting, monitoring, and maintaining the CAPA System through quarterly meetings and ensuring appropriate reporting and review is maintained and documented.
- Oversight of post market activities, document control activities, supplier assessments and approvals, statistical analysis including critical metrics, product inspection, and product release.
Minimum Requirements / Qualifications :
- BA / BS in biology, chemistry, engineering, or other medical device related field.
- Ability to manage teams in the implementation of quality plans and programs.
- Interpersonal skills and ability to foster teamwork.
- Organizational skills, including project management, with attention to details.
- Self-directed initiative and ability to communicate effectively in writing.
- Four to six years’ experience in quality, preferably in medical devices.
- Knowledge and understanding of the Medical Device industry, in vitro diagnostics and related FDA QSR / QMS Regulations.
- Experience in auditing quality systems for medical devices.
Non-Negotiable Hiring Criteria :
- BA / BS in biology, chemistry, engineering, or other medical device related field.
- Four to six years’ experience in quality, preferably in medical devices.
- Experience in auditing quality systems for medical devices.
- Successful management of teams.
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