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Quality Assurance Technician
Full-Time |
Reference Job 07-1029 |
POSITION SUMMARY:
Support manufacturing and quality assurance groups to ensure quality product and compliance with quality system policies and procedures, FDA and international requirements, and ISO Standards for Class III Medical Devices.
DUTIES & RESPONSIBILITIES
- Examine and use prints, schematics, work instructions and procedures.
- Responsible for the maintenance of the NCMR program.
- Responsible for ensuring SPC data is accurate and collected in a timely manner.
- Assist in the analysis and reporting of SPC data.
- Assist in more complex inspection and verification of materials and product and associated documentation.
- Assist and perform quality systems training to company employees.
- Assist in the establishment of accept/reject limits for product.
- Assist and perform disposition, analysis, and reporting of deviations and NCMRs.
- Assist and perform trending and reporting of NCMRs, internal and external yields, and supplier corrective actions.
- Assist and perform quality system audits.
- Support manufacturing and receiving inspection in quality control activities; including identification of quality issues effecting product and containment of discrepant material.
- Support the CAPA system.
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POSITION QUALIFICATION REQUIREMENTS
- Bachelors degree, or Associates degree with 2 years related experience (medical device experience preferred), or equivalent.
- ASQ Certified Quality Technician (preferred).
- Strong verbal and written communication skills required.
- Strong organizational skills.
- Detail-oriented and self-directed.
- Knowledge of quality control and quality standards, handbooks, and specification.
- Sound working knowledge of computer software [Microsoft Word, Microsoft Excel] (required) along with various statistical programs [Minitab, SPSS, WinSPC] (preferred).
- High level of aptitude for data/trend analysis, troubleshooting, and problem solving.
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Contact Information
opportunities@cameronhealth.com
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