Quality Specialist (Regulated Industry)

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, PR, Boston, MA & San Francisco, CA and we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

Responsibilities:

1. Performs all functions listed below with direct supervision.
2. Support to issue and solve internal corrective measures report.
3. Ensure current service/product quality specification fulfill client’s requirements.
4. Support Quality Management Systems operation within organization.
5. Provide support for design, execution and maintenance of quality system processes at respective departments.
6. Help department to coordinate training to operating procedure changes or new system implementation.
7. Ensure operating procedures are of use to end users.
8. Direct writing and review operating procedures (OP’s) to ensure compliance, efficiency and clarity.
9. Participate in corrective action discussions as necessary.
10. Revise department complaints and implement corrective actions for clarity and fullness in investigations.
11. Comply all activities with MTG’s policies as well as departmental procedures to reduce risk and losses.
12. Ensure program activities are in compliance with applicable government regulations and company quality assurance standards.
13. Recommend, implement and direct others to modify operational methods and practices along with overall strategy to enhance department effectiveness.
14. Support the Quality Manager in Client Internal Audits.
15. Comply with the ISO Certifications ISO 9001 and ISO 17025.
16. Prepare evaluation reports and submit them to Quality & Customer Service Manager.
17. Function as an information source for bottlers and other departments when critical quality issues arise.
18. Establish and manage professional customer rapport to drive solutions to attain business needs.
19. Other responsibilities as assigned by supervisor/management.

• Degree in Engineering, Science, or related curriculum
• Bachelor's Degree preferred