Quality Assurance Specialist Job

QUALITY ASSURANCE SPECIALIST needed for a contract opportunity with Yoh's client located in Issaquah, WA.

The Big Picture - Top Skills You Should Possess:

- Experience with Document Control, CAPA, Complaint and Training systems
- Experience in a medical device or pharmaceutical industry

WHAT YOU'LL BE DOING:

The QA Specialist is primarily responsible for Document Control activities, including maintenance of the Complaint, CAPA and Training systems. The QA Specialist also provides Administrative support to the department in terms of compilation of the various reports required both internally within the department and externally.

- Leading the maintenance of Quality Assurance System databases, including but not limited to:
- Document Control and MyWorkshop database maintenance
- Complaint delegation and CSSx database maintenance
- CAPA investigation and TrackWise database maintenance
- Audit Metrics
- Production and Process Control Metrics
- Training workflow submission and record retention
- Supporting the preparation of Quality Management Reviews at the site

Quality Specific Goals:

- Process all quality management system document changes according to requirements
- Ensure on-time reporting of the CAPA, Complaint and Training monthly metrics
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality and Compliance training within the defined deadlines

What You Need to Bring to the Table:

- Experience with Document Control, CAPA, Compliant and Training systems.
- Experience in investigation of cases and discernment in referral to subject matter experts
- Proficient with MS Office word processing, spreadsheet, presentation, and database applications.
- Able to identify root cause of problem and creatively problem solve to gain resolution.
- Able to communicate effectively in English (both written and oral).
- Able to work independently in fast-paced environment with little supervision.
- Able to adapt to constant change and influence positive change effectively.
- Team-oriented and responsive to customer needs.
- Quality-Focused, Attentive to Detail and Results-Oriented

Bonus Points! Otherwise Known As Preferred Qualifications:

- Experience complying with quality regulations in QA role (including FDA QSRs, ISO13485).
- Experience in a medical device or pharmaceutical industry.
- Statistics education and or training
- Experience developing and tracking quality metrics
- Familiar with Continuous Improvement methodologies including Six Sigma
- S. Degree in business or technical field

IF THIS SOUNDS LIKE YOU, APPLY NOW!

RECRUITER: Rene Borst

Yoh, a DayJ2W: SCIENTIFIC; J2W: PROF

MONJOBJ2WPACNW

Ref:

SFSF: LS