Quality Engineer

Job Description Quality Engineer B&J Medical is seeking a detail-oriented Quality Engineer to support quality assurance and regulatory compliance within our medical device manufacturing environment. This role is responsible for maintaining quality systems, investigating non-conformances, supporting audits, and driving continuous improvement initiatives. Responsibilities: Develop and maintain quality processes in compliance with ISO 13485 and FDA regulations Conduct audits, inspections, and quality investigations Lead root cause analysis and corrective/preventive actions (CAPA) Review engineering changes, specifications, and manufacturing processes Support continuous improvement and process optimization initiatives Create and maintain SOPs, work instructions, and quality documentation Collaborate with production, engineering, and quality teams to resolve issues Qualifications: Bachelor's degree in Engineering, Quality, or related field preferred 3–5 years of Quality Engineering experience in medical device or regulated manufacturing Strong understanding of QMS, ISO standards, CAPA, FMEA, and quality tools Excellent analytical, problem-solving, and communication skills Experience with audits, inspections, and process improvement initiatives Work Environment: Full-time day shift Climate-controlled, clean manufacturing facility Competitive pay based on experience B&J Medical is an equal opportunity employer committed to quality, teamwork, and continuous improvement. 1st shift, Monday - Friday, 7:00am - 4:00pm