JOB SUMMARY: Our client primarily manufactures Class I Medical Devices used for patient positioning in the Operating Room. This role has Operations Quality Technician responsibility to support the production activities for these products.
ESSENTIAL DUTIES AND RESPONSIBILITIES – Other duties may be assigned:
- Serves as QA technician for operational quality functions in production.
- Routinely identify and assist in mitigation of product/customer risk.
- Support QE and Manager to deploy efficient and effective corrections to quality problems in a manner that prevents their reoccurrence using our internal listening systems (ie Internal Audits, NCEs, and CAPAs).
- Use a variety of different measurement equipment to inspect components/devices.
- Facilitate the Tool/Fixture calibration/certification program.
- Assist in NCMR activities.
- Create, edit, and own applicable change control processes using ECO and Doc Change systems under manager guidance.
- Lead small Continuous Improvement Projects.
- Competent in Gage R&R studies
- The ability to work under the direction of Operations Quality Manager to resolve quality issues in a dynamic environment while flexing priorities day to day.
- Quality Technician Medical Device experience preferred with strength in Operational Quality a plus.
- Familiarity of QSRs, ISO 13485, and ISO Quality System Standards
- Have good analytical & data decision making with sound problem solving skills. Having experience using root cause analysis tools a plus.
- Ability to partner & communicate well with internal customers, peers, as well as leadership positions.
- Computer literacy skills in applicable programs to position (MS Office in Windows OS)
- Green Belt certification in Lean Six Sigma a plus, or at least an understanding of DMAIC phased approach to problem solving.
- Certified Quality Improvement Associate (CQIA) a plus
EDUCATION AND/OR EXPERIENCE:
- Prefer 5+ years of related quality technician experience
- Prefer some experience in a medical device or other FDA regulated industry required