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Sr. Quality Specialist

Aerotek • Kirkwood, MO

Posted 2 months ago

Job Snapshot

Biotechnology, Medical Equipment
Biotech, QA - Quality Control, Science

Job Description

Aerotek is on a search for a Sr. Quality Specialist. The Senior Quality Specialist will be responsible for Corrective and Preventive Action (CAPA) and Non-conformance (NC) processes and related quality activities. The position also supports new quality system/methodologies implementation, training, and problem solving.
This position will also work directly with Site Quality, Global Quality and Site Functions and Departments to provide sustaining quality and compliance leadership in the specific areas related CAPA and Non-conformance, training, and problem solving. In addition, the position is responsible for reporting key quality metrics to drive quality and efficiency.
- Will develop and maintain Nonconformance and CAPA procedures in accordance with applicable requirements.
- Supports compliance remediation projects.
- Facilitate implementation of CAPA and NC systems.
- Mentor, coach, and guide users of the CAPA and NC systems, including; problem solving tools, root cause investigation, CAPA action determination, CAPA effectiveness.
- Monitor quality of CAPA and NC records and work with owners to address issues.
- Contribute to the continuous improvement of the CAPA and NC systems based on use patterns and user feedback.
- Develop, implement and manage CAPA Review Board.
- Develop and report quality metrics on CAPA and NC performance.

This role collaborates with other NC Owners to help them write more robust CAPA's, stay on track, build efficiencies, and effectiveness. Will involve some technical writing or coaching others on technical writing. Will provide final NC/CAPA closure review


BS Degree in Science/Engineering
-Minimum 5 years of Quality/QA experience in an FDA environment (Pharma/Med Device)
3+ years demonstrated working experience and expertise in CAPA and non-conformance systems
-Specific experience in root cause analysis and statistical techniques such as Cause and Effect Analysis, 5 Whys, Six Sigma processes.
-ASQ Certification (such as CQA, CQE, CMQ/QE). Preferred
-Lean Six Sigma Certification. Preferred
Familiar with 21 CFR Part 820 and ISO 13485. Preferred.
-Experience in electronic quality management systems. Preferred.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.
Job ID: 6757904
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