Quality Assurance Analyst

Reports to:  Director of Regulatory/QA

Education Requirements: Technical degree or specific experience in related field with cGMP and ISO9001/13485 or IVD compliance requirements.

Experience/Qualifications:  

• Knowledge of cGMP and ISO 9001/13485 systems
• Ability to analyze and interpret data and results
• General MS Office computer skills including experience with inventory management systems
• Accuracy in recordkeeping and in sorting, checking, counting and verifying items
• Problem solving skills and troubleshooting abilities.
• Knowledge of product/process validations.
• Ability to work cooperatively as a member of a team - position will interact with multiple operational units
• Detail oriented and good time management skills
• Excellent interpersonal, written, and oral communication skills with ability to articulate with accuracy and detail

Physical Effort:  Listed below are the physical demands of the job according to percentage of time performing the tasks including any applicable weight movements.

Summary of Position:

Individuals serving in this position will be responsible for coordinating quality programs in compliance with ISO 13485 including the CAPA program, supplier quality, and internal audit program.

Job Duties/Key Responsibilities:

1. Coordinate the Internal Audit program by creating the internal audit schedule, scheduling audits and following up with any corrective actions required.
2. Manage the CAPA program by logging CAPAs as they occur, conducting monthly CAPA meetings, and guiding the process to completion.
3. Writing and updating quality assurance procedures
4. Ensure Supplier Quality by qualifying all new vendors, forwarding quality agreements, conducting annual supplier performance evaluation, submitting revisions to the Approved Vendor List (AVL), and conducting supplier audits as needed.
5. Investigate and complete Non-conforming material reports (NCRs)
6. Participate with external (regulatory and customer) audits
7. Collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations for management review
8. Assist with updating product risk assessments, procedures, reports, etc. as regulations change
9. Provide recommendations for the improvement of existing processes
10. Other projects as assigned.