Quality Engineer

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 lbs. 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. Job Details Seniority level: Mid-Senior Employment type: Full-time Job function: Quality Assurance Industries: Plastics Manufacturing #J-18808-Ljbffr