Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Acts as the primary Quality Assurance contact 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 and validation.
- Reviews quality records for all related areas of responsibility.
- Supervises QA personnel, including daily task management, training plans and performance management.
- Serve as qualified quality auditor for internal and supplier audits.
- Generates, reviews, approves and maintains QMS documents.
- Provides various forms of customer support (ex. Inquiry responses, customer surveys, declarations of conformity).
- Provides data for and participates in Quality Management Reviews.
- Participates in external audits (regulatory or customer) as a QMS subject matter expert and for administrative support.
- 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.
- Other responsibilities as needed.
- Other projects or responsibilities as may be required.
