Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Acts in a support capacity for critical QMS processes such as, non-conformances, complaint management, field corrective actions, risk management, design control, CAPA, document and change control, training, batch release, auditing, supplier Management and validation.
- Reviews quality records for all related areas of responsibility.
- Demonstrates the ability to work with limited direction and can prioritize projects independently.
- Responsible for personal daily task management, training plans and performance management.
- Assist with generating, reviews and maintains QMS documents.
- Assist with monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
- Assists with data preparation for Quality Management Reviews.
- Provides administrative support for external audits (regulatory or customer) and Internal Audits.
- Participates in the use of the eQMS system and expanded applications as appropriate.
- This position will interact with key internal stakeholders in Manufacturing, Facilities, IT, R&D, Customer Support and Supply Chain.
- Assist with monthly and management review data and metrics for areas of responsibility.
- Other projects or responsibilities as may be required.
Minimum Qualifications – Education And Experience
- BA in a scientific discipline or equivalent work experience.
- 1-year work experience in quality assurance.
- Proficient in MS Word, Excel, Powerpoint, Adobe Acrobat (PDF).
Preferred Qualifications – Education And Experience
- IVD, MDSAP, ISO 13485 or similar compliance experience.
