
Quality Compliance Specialist
Manage the Supplier and Vendor Management Program and ensure compliance with all relevant quality management systems. Interact with cross-functional departments to provide quality guidance and training on supplier management quality and regulatory requirements. Provide oversight and facilitate timely closure of SCARs, Non-conformances, Deviations, and CAPAs related to supplier quality issues.Conduct supplier quality related investigations thorough root cause analysis. Execute part number and specifications process while ensuring the maintenance of the part numbering data base. Conduct internal and supplier audits including executing audit plan, report, and follow-up on response closure. Support regulatory and accrediting body inspection activities and represent the Supplier Management Program as a subject matter expert. Write, revise, and review controlled documents and training materials to support supplier and vendor management and audit program.
Supplier Management and Audit knowledge in a medical device/IVD organization desired
Knowledge of international, US Federal, state laws, and standards (FDA, CLIA, CAP, NYS, ISO)
5+ years in a life sciences discipline with a focus on Supplier Management QMS and Auditing
Quality related training/certification (CQA-ASQ) desirable
MS Visio
MS Project
Supplier management
Great time management
Excel skills
PowerPoint skills
Team player
Verbal communication
Prioritizing skills
written communication
Flexibility/Adaptability
Attention to detail and accuracy
Multi tasker
According to JobzMall, the average salary range for a Quality Compliance Specialist in 7 Argonaut, Aliso Viejo, CA 92656, USA is $60,000 to $100,000 per year. This range is based on the experience and qualifications of the specialist. Factors such as the size and complexity of the company, as well as the amount of experience and qualifications of the individual, can affect the salary range.
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