Quality Engineer

REPORT TO : QUALITY MANAGER PURPOSE : Responsible for supervising and coordinating activities of quality assurance personnel, assist Quality Manager in all aspects of the Quality Department. ESSENTIAL FUNCTIONS :

• Maintain discipline, morale, harmonious personnel relations; handle complaints in accordance with company policy; conduct interviews and employee performance evaluations; make effective recommendations for increases, promotions, transfers, hiring and terminations.
• Assist in managing and maintaining ISO 9001, 14001, 13485, TS 16949 standards and FDA 21 CFR 820 regulatory compliance.
• Development, implementation, monitoring, assessment, and continuous improvement of applicable quality standards.
• Supervise day to day plant quality control functions, investigate discrepancies, and issue corrective actions against persistent non-conformances.
• Assist in administration of Corrective and Preventive Actions (CAPA).
• Perform compliance and layered process audit of quality system and processes to ensure effectiveness of procedures and instructions.
• Participate in APQP and validation of processes as required. Assist in setting up quality standards for new products.
• Work with appropriate managers and supervisors to ensure timely resolution of outstanding quality concerns.
• Enforce prescribed safety rules and regulations; ensure that work areas are maintained in a neat and orderly condition.
• Assist in change management and quality control documentation, including part specific instructions and procedures. ADDITIONAL SKILLS OR CREDENTIALS :
• Associate or Bachelor’s degree in Engineering or Technology. Equivalent combination of education and experience will be considered in lieu of a degree.
• 3+ Years of experience in quality control functions, including but not limited to APQP, PPAP, AIAG core tools (FMEA, Control Plan, etc.).
• Knowledgeable in ISO and Automotive (ISO / TS 16949), ISO 13485, ISO 9001 and ISO 14001 standards.
• Knowledge of FDA 21 CFR 820 would be a plus.
• Excellent verbal and written communication skills.
• Demonstrated hands-on approach to daily challenges.
• Experience in writing procedures, instructions and 8D-5Why reports.
• Experience or knowledge of layered audits would be a plus.
• Experience training other employees (preferred) Physical Demands :
• While performing the duties of this job, the employee is regularly required to walk, use hands to position or move, reach with hands and arms, talk, and hear.
• The employee frequently is required to stand, sit, climb, balance, stoop, kneel, crouch, or crawl.
• The employee must regularly lift and / or move up to 10 lbs., frequently lift and / or move up to 25 lbs. and occasionally lift and / or move up to 40 bs.
• Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
• Must be able to lift 40 lbs.
• Must be able to be on feet for extended periods of time, up to and exceeding 8 hours.