Director Of Quality Jobs

Director of Quality

Summary

• The Director of Quality will ensure effective and comprehensive quality strategies as well as the development and validation of appropriate methods for design and manufacture of products and components
• The role includes ensuring effective and efficient use of Quality techniques such as risk analysis, test method development, statistical data analysis, and the development of sample plans
• This person will assume the role of Quality Management Representative and will lead all internal and external audit functions.
• Will drive the thorough investigation of quality issues and effective corrective and/or preventative action
• This role will provide guidance to project teams, suppliers, and other disciplines to ensure compliance with company policies and procedures as well as applicable medical device regulations
• The Director of Quality will be responsible for the design, implementation, and proliferation of the Quality Management System in accordance with 21CFR820 and ISO13485

Essential Functions

• Lead internal and external quality related audit programs.
• Evaluate and recommend QA sampling plans based on desired confidence limits, process capabilities, and manufacturing/inspection methods and equipment.
• Manage supplier site audits and works with suppliers to improve quality of applicable services and internal processes.
• Work with executive staff in quality planning, both short term and long term, driving diagnosis of quality problems, corrective and preventive action programs and maintaining the quality system.
• Interface with suppliers to assure quality and reliability of the design during transfer to manufacturing, including overseeing and support of quality programs and/or issues at the supplier’s site.
• Utilize standard statistical analysis techniques to determine product acceptance, evaluate process capabilities, and develop statistically sound tolerance limits based on product specifications.
• Actively participate in all aspects of design control, including quality planning, FMEA, risk analysis, design reviews, and packaging.
• Assist manufacturing in a quality capacity improving with inspection, quality system requirements, and process validation.
• Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA Engineering areas of expertise.
• Represent Quality during product development and design reviews.
• Identify nonconformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems and to improve supplier quality.
• Responsible for FDA / GMP compliance

Education/Experience

• Experience designing, implementing, and sustaining a Quality Management System in accordance with 21CFR820 and ISO13485.
• Minimum 15 years of Quality functional leadership experience, preferably in an FDA or highly regulated environment.
• B.S. Engineering or related field.

Technical Skills/Requirements

• Proven ability to recruit, motivate, and develop a professional, high performing staff.
• Superior business leadership skills and acumen along with a demonstrated ability to weigh the financial needs of the business with the investments necessary to achieve the quality goals of the business.
• Proven success at the senior leadership level which demonstrates the candidate’s ability to deliver clear business value from the Quality function.
• Excellent project management skills and the ability to organize and manage multiple priorities.
• Excellent communication skills and the ability to take complex situations, simplify them, and break them down to their fundamental elements to enable meaningful discussion.
• Experience partnering with a senior leadership team in an environment of consistent growth and changing business cultures.
• Experience with developing meaningful metrics and measures that fairly and accurately indicate the quality performance of the business.
• Experience and familiarity with modern Quality Assurance techniques including Advanced Product Quality Planning (APQP), Production Part Approval Process (PPAP) and Design for Six Sigma (DFSS).
• Experience leading the Quality function in a multi-site manufacturing organization with quality responsibility for our Missouri and Florida plants.
• Experience in developing and executing a successful Quality strategy.

Travel

• Willing and able to travel up to 15% of the time.