Senior Quality Assurance Manager
1 week ago
We are a dynamic and global company seeking a highly skilled Senior Manager, Quality and Regulatory to join our team. As a key member of our organization, you will be responsible for implementing and executing our Quality program across all products, raw materials, processes, and services.
Key Responsibilities:- Quality Program Implementation: Develop and execute a comprehensive Quality program that ensures all products, raw materials, processes, and services meet our exceptionally high-quality standards.
- Regulatory Compliance: Ensure company compliance with accredited quality systems, including 21 CFR part 820, ISO 13485, and applicable EU, UK, and Australian requirements.
- Quality System Evolution: Continuously evolve and improve our quality system to meet changing standards and regulations.
- Management Representative: Act as Management Representative and perform all duties and tasks associated with that designation, including PRRC for European compliance.
- Audits and Quality Data: Lead company audits and maintain quality data, including complaints, nonconforming product, and corrective/preventive action activities.
- Problem-Solving and Continuous Improvement: Perform problem-solving tests to develop corrective actions for quality issues and initiate continuous improvement.
- Education: Bachelor's degree from an accredited higher learning institution, preferably in a Quality or Engineering related field.
- Experience: Minimum of 10 years' experience related to quality assurance, lean manufacturing, regulatory compliance, and/or Six Sigma manufacturing.
- Certifications: Holds Quality certifications in one or more of the following: ASQ/CQE, CMQ/OE, Six Sigma (Green or Black Belt).
- Skills: Strong organization, persuasion, and negotiation skills, with excellent communication skills, both written and verbal.
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