Director Of Quality Assurance

Requirements

Essential Functions:

• Work with executive staff in quality planning, driving diagnosis of quality problems, corrective and preventive action programs and maintaining the quality system.
• Utilize standard statistical analysis techniques to determine product acceptance, evaluate process capabilities, and develop statistically sound tolerance limits based on product specifications.
• Participate in design control, including quality planning, FMEA, risk analysis, design reviews, and packaging.
• Assist manufacturing in improving with inspection, quality system requirements, and process validation.
• 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.
• Represent Quality during product development and design reviews.
• Responsible for FDA / GMP compliance
• Provide technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other QA Engineering areas of expertise.
• Identify nonconformance trends and develop and administer technical investigation and corrective action programs to resolve recurring quality problems and to improve supplier quality.
• Lead internal and external quality related audit programs.

Qualifications

Education/Experience:

• Experience designing, implementing, and sustaining a Quality Management System in accordance with 21CFR820 and ISO13485.
• B.S. Engineering or related field.
• Minimum 8 years of Quality leadership experience, preferably in an FDA or highly regulated environment.

Technical Skills/Requirements:

• 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).
• 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.
• Experience in developing and executing a successful Quality strategy
• Experience leading the Quality function in a multi-site manufacturing organization.
• Excellent project management skills and the ability to organize and manage multiple priorities.