Lead Quality Engineer
The Lead Quality Engineer Responsible for ensuring product & service meets the established standards of quality including reliability, usability and performance. Oversees inspection and testing of materials, parts, and products to ensure adherence to established standards of strength, quality, and endurance. Also responsible for operating mechanical and electrical test equipment to check apparatus for conformance to standard requirements. A Lead Quality Engineer has authority for personnel actions and oversees most day-to-day operations of the Quality group.
- Draft quality assurance policies and procedures
- Interpret and implement quality assurance standards
- Evaluate adequacy of quality assurance standards
- Devise sampling procedures and directions for recording and reporting quality data
- Review the implementation and efficiency of quality and inspection systems
- Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
- Document internal audits and other quality assurance activities
- Investigate customer complaints and non-conformance issues
- Collect and compile statistical quality data
- Analyze data to identify areas for improvement in the quality system
- Develop, recommend and monitor corrective and preventive actions
- Prepare reports to communicate outcomes of quality activities
- Identify training needs and organize training interventions to meet quality standards
- Coordinate and support on-site audits conducted by external providers
- Evaluate audit findings and implement appropriate corrective actions
- Monitor risk management activities
- Responsible for document management systems
- Assure ongoing compliance with quality and industry regulatory requirements
- Responsible for the training & performance review of personnel in department.
- Quality inspection, auditing, & testing experience
- ISO or ISO 13485, Medical Device experience, preferred, not required.
- Manufactured components experience
- SPC- Statistical Process Control experience preferred
- Leadership, mentoring, coaching and training
- Experience with implementation of corrective action programs
- Product or industry-specific experience
- Strong computer skills including Microsoft Office and databases
- Knowledge of tools, concepts, and methodologies of QA
- Bachelor’s degree preferred or 5 years of relevant experience
- Certifications including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six Sigma would be preferred, not required.