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Operational Excellence - QA Manager

Company Name:
s-t-i
Operational Excellence - QA Manager
Company Work Location: Hayward, CA
Candidates must have Green card or US Citizens ONLY
Position Summary:
We are looking for a leader to Manage and support our Diagnostics Manufacturing. This person will work to achieve and sustain a best-in-class Quality Assurance System meeting requirements of the FDA QSR (FDA 21CFR820), ISO-13485:2012 quality standard.
Responsibilities:
& Assures consistent quality of production by developing and driving quality assurance projects to achieve Quality System compliance, product quality and reliability in accordance with current good manufacturing practice (cGMP) systems.
& Hires and manages staff to support Operational Excellence within the Dx Manufacturing environment
& Provides leadership and practical strategies towards shifting the culture in manufacturing to meet all requirements for producing Dx Instruments in a regulated environment.
& Responsible for compliance with our companys quality system requirements through training and adherence to policies, procedures and processes within a Dx manufacturing environment
& Establish and maintain awareness and knowledge of Good Manufacturing Practices, ISO13485 and Standard Operating Procedures.
& Supports Dx Manufacturing in maintaining compliance with all applicable regulations and standards. Stays current with US FDA and European Union IVD regulations and developments, QSR and ISO13485 compliance.
& Maintains and improves product quality by completing product compliance, and surveillance audits; investigates customer complaints; manufacturing and training methods.
& Prepare manufacturing for internal and external quality audits (FDA, Notified Bodies, WHO), risk management, process mapping and writing and reviewing QA and other SOPs
& Validates quality processes by establishing product specifications and quality attributes; measuring production processes; documenting evidence, writing and updating quality assurance procedures.
& Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
& Oversee and periodically review document records, design control, CAPA, personnel training, and customer complaints functions.
& Coordination, planning and support of product and process validation.
Requirements:
10+ years experience within an FDA and ISO 13485 operations or quality organization
Experienced in Organizational Culture Change, Leadership, Process Improvement, Quality Systems
Requires Attention to Detail, Thoroughness, able to managing complexity and ambiguity
Experience with Lean/Six Sigma methodologies with strong program and project experience
Minimum of 5 years experience implementing and leading projects and initiatives in Operations or Quality
Education:
Bachelor Degree in Engineering, Quality Assurance, Biomedical, or other technical field
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