Sr Director Quality

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Requirements:

• 10+ years of prior work experience
• ISO13485, ISO9001, FDA 21CFR part 820, GMP; MDD
• Multi-site leadership experience
• Must have multiple product type experience:  Devices, IVD (in-vitro diagnostic), electro-mechanical equipment, pharmaceutical
• Must have led quality for a manufacturing site
• Must have had design/R&D quality experience
• Must have experience building relationships and working with customers

Responsibilities:

• Interactions with Flex Customers to define quality requirements for new product introductions.
• Prepares and implements QA Policies and Procedures.
• Reviews discrepancy reports and implements corrective actions.
• Reports progress to customers as required. Maintains contact with customers to ensure their business needs are met or exceeded.
• Conducts presentations to staff as required.
• Establishes QA objectives and creates plan of action.
• Cooperates with top management personnel in formulating and establishing company policies, operating procedures and goals.
• Evaluates content of reports from product assurance program department heads and confers with top management in formulating fiscal budget for product assurance program.
• Confers with engineering about quality assurance of new products designed and manufactured.
• Reviews technical publications, articles and abstract to stay abreast of technical developments in industry.
• Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.
• Travel to customer sites (when necessary) and to flex manufacturing sites globally to assist with New Product Introductions.