Senior Quality Specialist
- US$43 - US$50 per hour + Benfits
- Dallas, Texas
- Medical Devices, Quality Assurance (QA), Quality Assurance (QA), Operations, R&D, Regulatory Affairs (RA)
Looking for an exciting new challenge within the ever-growing Medical Device industry? Look no further! My client, a leading medical device firm in the Dallas area, is actively recruiting for a Sr. Quality Specialist. This will be 6 month contract, likely to extend.
As a core member of the team, the Sr. Quality Specialist is an influential leader who has responsibility for strategic oversight and direction. The Sr. Quality Specialist will Lead, coach and develop all personnel within the Quality team to continually improve quality performance, and manufacturing efficiency.
Among others, the Sr. Quality Specialist manager will have the following responsibilities:
- Maintain ISO and MDSAP certifications for company
- Maintain and enhance QMS development to ensure full audit-readiness
- Ensure effective supplier management program is implemented and active
- Establish systems and documentation required for the implementation and maintenance of a 21 CFR Part 820 total quality system and compliance to applicable International standards, such as ISO 13485 MDD/MDR, CMDR, TGA, Canada, EU, MDSAP, etc
The best candidates for Sr. Quality Specialist will have the following qualifications:
- Bachelor of Science (B.S.) degree in Engineering, Science, or related field.
- Deep understanding of Quality systems, MDSAP, ISO 13485:2016, FDA, and international Quality regulations
- Has undergone MDSAP audit and transition (must have MDSAP experience)
- Strong supplier management skills both domestic and international, certified auditor (CQA)
- 5+ years medical device experience
This is truly an amazing opportunity to join a high-functioning team within the Medical Device industry. The Sr. Quality Specialist at this firm is offered unlimited growth potential and can help you gain market leading skills and capabilities.
The Hiring manager is looking to move ASAP, if you would like to learn more please send me your resume and a time to call you.
Sthree US is acting as an Employment Business in relation to this vacancy.