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.
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Develop and maintain quality processes in compliance with ISO 13485 and FDA regulations
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Conduct audits, inspections, and quality investigations
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Lead root cause analysis and corrective/preventive actions (CAPA)
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Review engineering changes, specifications, and manufacturing processes
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Support continuous improvement and process optimization initiatives
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Create and maintain SOPs, work instructions, and quality documentation
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Collaborate with production, engineering, and quality teams to resolve issues
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Bachelor’s degree in Engineering, Quality, or related field preferred
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3–5 years of Quality Engineering experience in medical device or regulated manufacturing
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Strong understanding of QMS, ISO standards, CAPA, FMEA, and quality tools
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Excellent analytical, problem-solving, and communication skills
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Experience with audits, inspections, and process improvement initiatives
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Full-time day shift
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Climate-controlled, clean manufacturing facility
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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
