Purpose and role of job:

To provide leadership for quality-assurance support on assigned program(s) and/or areas to ensure that the product is designed, procured, and built in accordance with customer and industry quality requirements. To provide leadership for new systems development, implementation, procedures, and any related quality activity.

Principal Accountabilities/ Responsibilities:

• Supervises the activities, performance review and disciplinary actions of assigned staff.
• Understands and performs quality testing according to approved procedures.
• Regularly reviews quality data to identify opportunity for corrective & preventive action.
• Ensures that statistical methods are applied to testing, validation, sampling and inspection activities and quality investigations.
• Participates in and leads teams in quality system improvement, new product development, cost savings, and other quality initiatives.
• Coordinates the resolution of customer complaints/non-conformance issues.
• Acts as primary QA contact in supplier assessment and raw material qualification activities.
• Participates in internal and customer audits of the quality system.
• Oversees proper use and control of QA Department quality records.
• Devises or revises procedures related to the Quality Management System.
• Reports significant issues or developments identified during quality activities and provides recommended process improvements to management.
• Prepares and presents quality system information to team members.
• Performs laboratory tours and provides Quality System explanations to visitors.
• Observes all safety rules and uses the proper safety equipment at all times.
• Follows necessary GMP, and regulatory requirements.
• Performs other duties as necessary when directed to do so.
• ASQ Certification or equivalent training (CQA or CQT required; CQE preferred).
• Familiarity with formal Quality System (ISO 9001, GMP/QSR, etc.)
• Strong communication skills.
• Demonstrated team leadership ability.

Education and experience requirements:

• Bachelor’s degree in Engineering discipline and two or more years in quality or manufacturing engineering, (or) Bachelor’s degree in a scientific/technical field with five or more years experience in quality or manufacturing engineering disciplines.
• Experience in statistics, procedure implementation, and quality auditing preferred.