MedTech Quality Engineer – Validation, CAPA & QA Lead

BD; Delran Township (NJ); On-site; USD 84,000 - 134,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Medical coverage

401(k) plan

Life insurance

Job summary

BD Delran, a leading medical technology company, seeks a Quality Engineer to author, review and approve QMS documents and records to support quality objectives. You will serve as the quality representative on project teams and help resolve issues from nonconformances to CAPAs.

You will lead validation activities, support manufacturing and sustaining projects, review inspection records and MRBs, and participate in audits and continuous improvement initiatives.

Qualifications

• Bachelor's degree required in Biomedical/Engineering or related field.
• 3 years experience in medical devices/manufacturing in a Quality Engineering role or equivalent.
• Knowledge of FDA QSR and ISO13485 and quality systems.

Responsibilities

• Author, review and approve QMS documents and records to support BD Delran plant quality objectives.
• Act as the quality representative on project teams to address quality concerns and drive improvements.
• Lead validation activities for new products, processes, and equipment changes including protocols.
• Investigate quality issues, nonconformances, NCRs, and support CAPA disposition and MRB processes.
• Review inspection records, environmental monitoring data, and Lot History Records for compliance and accuracy.

Skills

Quality engineering

MS Excel

Minitab

Regulatory knowledge (FDA QSR/ISO13485

Communication skills

Education

Bachelor's Degree in Biomedical/Engineering or related field

Tools

Minitab

MS Excel

Job description

BD Delran, a leading medical technology company, seeks a Quality Engineer to author, review and approve QMS documents and records to support quality objectives. You will serve as the quality representative on project teams and help resolve issues from nonconformances to CAPAs.

You will lead validation activities, support manufacturing and sustaining projects, review inspection records and MRBs, and participate in audits and continuous improvement initiatives.