MedTech Quality Engineer: On-Site, Growth & Impact

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

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Health benefits

Job summary

BD Delran plant seeks a Quality Engineer to author, review, and approve QMS documents and records supporting BD quality objectives. You will be the quality representative on project teams, driving root-cause analysis and CAPAs across multiple initiatives.

Requires a Bachelor's in Biomedical/Engineering or related field and 3 years in medical devices/manufacturing quality. Proficiency with FDA QSR, ISO13485, Minitab, and Excel is preferred.

Qualifications

• Bachelor's degree in Biomedical/Engineering or related field.
• 3 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent.
• Knowledge of FDA QSR and ISO13485; strong communication and multi-tasking skills.

Responsibilities

• Lead validation activities and author/execute protocols for new product development and process changes.
• Provide technical and quality engineering support for manufacturing and sustaining projects.
• Investigate quality issues, initiate NCRs, support CAPAs and MRB processes.
• Develop and maintain quality documentation and ensure traceability of inspections.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Cross-functional teamwork

Education

Bachelor's degree in Biomedical/Engineering

Tools

Minitab

MS Excel

Job description

BD Delran plant seeks a Quality Engineer to author, review, and approve QMS documents and records supporting BD quality objectives. You will be the quality representative on project teams, driving root-cause analysis and CAPAs across multiple initiatives.

Requires a Bachelor's in Biomedical/Engineering or related field and 3 years in medical devices/manufacturing quality. Proficiency with FDA QSR, ISO13485, Minitab, and Excel is preferred.