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Quality Assurance Manager - Direct Hire

Placer County, CA

Posted: 06/11/2019 Employment Type: Direct Hire Position Industry: Management/Supervisor Job Number: 41227.1
We are recruiting a Quality Assurance Manager for a Biotech organization in Placer County. The QA Manager will maintain the quality management processes and ensure all activities promote customer satisfaction, meet regulatory requirements and positively impact the company's financial performance. This role will focus on continuous improvement efforts and defect reduction initiatives.

Responsibilities: Oversee quality control activities on a day-to-day basis. Serve as the primary QC resource for problem identification, resolution, loss reporting and continuous improvement. Educate and train employees regarding quality management processes. Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer. Review and document procedures for process control, process improvement, testing, and inspection. Maintain certification standards and where necessary, update/implement procedures to meet new requirements. Review departmental metrics (process capability, control charts, measurement quality) for monitoring system effectiveness.Perform root cause analysis and other problem-solving activities to identify effective corrective actions and process improvements. Act as Management Representative for CE and ISO activities. Report to management on quality issues, trends, and losses. Participate in internal and external quality audits.

Requirements: 10+ years' experience in QA systems implementation and management, with five (5) years in ISO 13485 certified manufacturing environment and/or with EU CE certified manufacturer. Bachelor's degree in mechanical engineering, electrical engineering, manufacturing engineering or business administration, or an equivalent number of years of experience. ISO Internal Auditor Training preferred. Excellent written and verbal communication skills. Problem solving and analytical skills. Solid time management, organization and decision making. Strong technical ability.

Salary: $120-$130k

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