Seeking a Senior QA Audit Specialist for a high growth medical device development client in the Scottsdale, AZ area. The QA Specialist would be responsible for supporting all quality system and functions for the facility.
Assists in establishing systems to support the facility to drive continuous improvements and minimize the costs of non-conformance. Plans, schedules, executes and communicates all items regarding quality issues, complaints, validations and other projects to the QA Manager and/or other interested parties.Performs all duties associated with compliance-related items for ISO standards and cGMps.
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location: Scottsdale, Arizona
job type: Permanent
salary: $85,000 - 100,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Participates in ISO and corporate quality system audits.
- Leads and assists in investigation of NCRs and CAPAs as necessary to identify and find the root cause of all product and related quality issues.
- Assumes responsibility for various assigned projects designed to improve product quality, reduce costs and/or validate facility products or processes, including development and implementation of any new or required inspection methods and in-process SPC programs.
- Assists facility with quality improvement programs by utilizing Six Sigma tools and Lean techniques, including the education of facility personnel on these tools and techniques.
- Maintains and reports information on statistics on facility quality performance, including Cost of Quality data.
- Organizes and leads CAPA Review Board meetings.
- Develops and implements best practices for root cause analysis and corrective action assignment and execution.
- Fills in for Quality Manager as requested or required.
- Promotes a culture of Quality First, Last, and Always throughout the organization.
- Performs other duties as required and/or assigned.
qualifications:
- Experience level: Experienced
- Minimum 3 years of experience
- Education: Bachelors (required)
skills:
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