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.

Salary : $63,000 - $85,000