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Position Description
Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. May serve as a liaison between the company and various governmental agencies. Provide leadership for customer-focused quality, quality systems improvements, and business process improvement initiatives.
Position Responsibilities
1. Oversee generation and review of documents used in good manufacturing practices; monitor audits of production and quality control areas.
2. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness.
3. Work in close collaboration and partner with other Physio-Control functions, including manufacturing, Finance/IT, Human Resources, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness.
4. Manage configuration management and document control, and provide oversight of related quality systems such as training and other electronic quality systems to ensure effectiveness.
5. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations.
6. Perform other related duties as assigned.
Basic Qualifications
• Bachelor’s degree in a technical or scientific field, preferably engineering
• Minimum of 8 years’ experience in quality and regulatory for medical devices or a combination of medical device and pharmaceuticals
• Minimum 6 years’ management experience in a complex environment
• Comprehensive knowledge of GMP and ISO 13485:2003 regulations, product design, manufacturing, supply chain, and distribution processes.
Desired/Preferred Qualifications
• Master’s degree in business or science
• Prior experience managing the quality system in a manufacturing environment
• Broad understanding of US and International regulations including 21 CFR, 820
• Influence management skills; demonstrated ability to work constructively across all functions of the organization
• Experience presenting, interacting, and building effective relationships with regulatory agencies
• Excellent communication and presentations skills (articulate and persuasive)
• Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Ability to translate quality initiatives into specific objectives, metrics, and action plans
• Willingness to “do what it takes,” including direct auditing activities at times
• Ability to attract, develop, and retain diverse talent
• Proven experience in achieving results through influence management and motivating teams
Physical Job Requirements
• Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse
• May require domestic and international travel (10-20%)
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