Director of Quality

Our client, a designer and manufacturer of mobility devices, is seeking a Director of Quality. You will be responsible for the design, implementation and proliferation of the Quality Management System.

Essential Functions:

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

Qualifications:

• B.S. Engineering or related field.
• Minimum 10 years of Quality leadership experience, preferably in an FDA or highly regulated environment.
• Experience designing, implementing, and sustaining a Quality Management System in accordance with 21CFR820 and ISO13485.

Technical Skills/Requirements:

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

Travel:

We are an equal opportunity employer and do not discriminate against otherwise qualified applicants on the basis of race, color, creed, ancestry, religion, orientation, age, sex, marital status, national origin, disability, genetic information, or veteran status.