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