Director of QA
Our client, a Medical Devices company, is looking for a Director of QA for their growing team in the Dominican Republic. The Director of Quality Assurance is responsible for the overall supervision and management for the Quality Assurance Department.This position will develop, implement and maintain the quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards, agency guidelines and customer expectations. The Director of Quality Assurance also provides leadership for customer-focused quality, quality systems improvements and business process improvement initiatives and Product Transfers.
DUTIES & RESPONSIBILITIES
• Oversee all Quality Systems and department functions, including coaching and leading the inspection and administrative support to ensure site compliance.
• Provide oversight of related quality systems such as training, work orders and procedure setup to ensure effectiveness and correct implementation.
• Develop and implement quality management strategy and plans, including resources, systems and timescales with the aim to support the organization’s business strategy.
• Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
• Implement all requirements of the Quality Management System including further procedure development as necessary.
• Manage and perform internal audits.
• Represent the company in all customer and agency audits including FDA QSR, Notified Body and ISO 13485.
• Update, proofread and approve procedures, specifications and other documents as needed.
• Work in close collaboration with all departments including Production, Regulatory Affairs, Supply Chain, Engineering, Quality Engineering and OEM customers to optimize overall operational efficiency and effectiveness.
• Update, proofread and approve IQ/OQ/PQ and EO Sterilization validation protocols, specifications and other documents as needed.QUALIFICATIONS
Bachelor's Degree in Engineering, Business Administration or other science field, preferred.
• 10 -15 years of progressive quality management experience. A minimum of 3 years in a QA Director role.
• Experience working in the medical device manufacturing industry required, contract manufacturing experience strongly preferred.
• Trained in ISO 13485: current revision standard
• Minimum of 2 years of EO sterilization experience and training on ISO 11135
• Must have expertise in medical device regulations and ISO standards including 21 CFR 820 and ISO standards.
• Solid leadership building quality systems and utilizing quality tools such as root cause analysis.
• Strong computer proficiency including Microsoft Office required.
• Detailed oriented with ability to interact professionally and manage technical documentationPLEASE APPLY TO THIS JOB ONLY IF YOU HAVE THE REQUIRED SKILLS ON THE JOB DESCRIPTION, OR IF YOU HAVE BEEN SENT HERE BY THE RECRUITER IN CHARGE OF THIS ACCOUNT.
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