Description
Qualifications and Responsibilities:
• Quality/Compliance Management experience with AS9100, ISO13485, NADCAP Chemical Processing: 5 years (Preferred)
• Audit Representative – Maintain Quality System in compliance with applicable standards including AS9100, ISO13485 and NADCAP Chemical Processing. Represent the company during all quality audits.
• Review, understand and implement internal and external customer requirements to establish, develop, and review quality criteria and specifications for raw materials, products, and processes.
• Ensure all quality criteria and requirements are met by incoming customer products and raw materials, and final product/finished goods.
• Develop, maintain and update written policies and procedures.
• Documentation and Revision Control
• Conduct internal audits on a periodic basis to verify compliance with applicable policies and procedures.
• Conduct supplier quality audits.
• Oversee Corrective Action/ Preventive Action program.
• Provide quality and compliance guidance and feedback to employees at all levels and functional areas.
• Solicit feedback from customers to assess whether their requirements are met.
• Submit detailed reports to appropriate Management.
• Key team member and contributor to Continuous Improvement Program.
• Product/process/machine validation (IQ/OQ/PQ) experience
Requirements
• 5 years preferred as Compliance/Quality Manager/ ISO Management Representative
• Proven excellent interpersonal, verbal, and written communication skills.
• Organizational, leadership, and project management skills
• Proficient in MS Office
• In-depth understanding of quality control/assurance procedures and standards
• Strong root cause analysis skills
• Knowledge of pFMEA (process failure modes effects analysis) completion
• Excellent math abilities and working knowledge of data analysis/statistical methods.
• Solid understanding of the current standard revisions of NADCAP Chemical Processing, iSO13485, and AS9100
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