MedTech Quality Engineer: Impact & Compliance (On-Site)

BD; New Jersey; On-site; USD 84,000 - 134,000; Full time

Job summary

BD Delran seeks a Quality Engineer to author, review, and approve QMS documents to support quality objectives. You will lead validation activities, investigate complaints, and drive CAPAs with cross-functional teams.

Responsibilities include reviewing inspection records, supporting audits, and ensuring regulatory compliance. A Bachelor’s in Biomedical/Engineering with 3 years of relevant experience is required, with on-site work at USA NJ Delran.

Qualifications

• Bachelor’s degree in Biomedical/Engineering or related field.
• 3 years experience in medical devices/manufacturing in a Quality Engineering role or equivalent.
• Experience with FDA QSR and ISO13485 preferred.

Responsibilities

• Lead validation activities, authoring and executing protocols for new product development and process changes.
• Provide technical and quality engineering support for manufacturing and sustaining projects.
• Identify root causes of nonconformances and drive improvements in processes and design.
• Investigate quality issues, initiate NCRs, and manage MRB processes.
• Develop and maintain quality documentation, inspection plans, test methods, and standards.

Skills

Quality engineering

Multi-tasking

Project planning

Communication

Team collaboration

Education

Bachelor’s degree in Biomedical/Engineering

Tools

Minitab

MS Excel

Job description

BD Delran seeks a Quality Engineer to author, review, and approve QMS documents to support quality objectives. You will lead validation activities, investigate complaints, and drive CAPAs with cross-functional teams.

Responsibilities include reviewing inspection records, supporting audits, and ensuring regulatory compliance. A Bachelor’s in Biomedical/Engineering with 3 years of relevant experience is required, with on-site work at USA NJ Delran.