Quality assurance specialist

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.
• Responsible for monitoring and trending QMS elements and providing metrics data for monthly reports, quality objectives and key performance indicators (KPIs).
• 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.

Minimum Qualifications – Education and Experience

• Bachelors degree in scientific discipline or equivalent experience. 3 years QMS experience working in a regulated, GMP environment

Preferred Qualifications – Education and Experience

• 3 years experience in IVD, including ISO 13485:2016 and MDSAP.

Work Environment & Physical Demands

Office

While performing the duties of this job, the employee regularly works in an office setting. Occasional exposure to a laboratory and warehouse environment.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use hands and fingers to handle, feel, or operate objects, tools or controls, and reach with hands and arms. The employee is frequently required to stand, talk and hear.