- Product Development
- FDA Regulations
- Six Sigma Certification
- ISO 13485
Job Description Summary
This position is responsible for authoring, reviewing and approving QMS documents and records, as required, to support BD Delran plant quality objectives. This position will act as the quality representative regarding quality interests and concerns on project teams as well as getting involved in a variety of projects which may include, resolving quality problems, improving areas of high quality costs, assisting suppliers and subcontractors in meeting BD Delran’s needs. Be an active team member for investigating quality complaints, examining non-conformances and executing CAPAs.
Essential Job Functions:
Perform validations, including authoring protocols, in support of, but not limited to, new product development, process changes/improvements and test methods.
Provide technical support to ongoing/sustaining projects.
Design and conduct quality engineering studies for the following: to determine root causes of quality non-conformances, to initiate changes in process, tooling, and/or product design.
Initiate nonconformance reports, assures segregation and identification of rejected material, lead investigations and make dispositions of rejected nonconforming products; perform Material Review Board actions.
Develop documented instructions for performance of QC Inspections, including quality plans, inspection and test procedures and quality standards.
Review and approve incoming, in-process test inspection records and environmental monitoring records .
Review lot history record (LHR) documentation for completeness and compliance to quality requirements.
Review and approve customer specifications/requirements.
Perform customer complaint investigations.
Schedule and/or perform measuring and monitoring equipment calibrations.
Participate and perform in external and internal audits and inspections, as necessary.
Other projects, as assigned.
Knowledge and understanding of quality and manufacturing.
Knowledge of product development objectives and strategies.
Experience with statistical software such as Minitab and MS Excel.
Applied knowledge of FDA QSR and ISO13485.
Good oral and written communication skills.
Demonstrated ability to multi-task.
Good project planning skills and ability to meet internal/external customer needs.
Ability to work with and motivate people.
Additional Desirable Qualifications Skills and Knowledge:
American Society of Quality Certified Quality Engineer (ASQ CQE) preferred.
ISO-13485:2003 Audit training and/or American Society of Quality Certified Quality Auditor (ASQ CQA), a plus.
Six Sigma Green/Black Belt Certification or similar, a plus.
Software qualification, a plus
Experience with textiles, a plus
Education and/or Experience:
Bachelor’s Degree in Biomedical/ Engineering or related field.
Minimum of 2 years experience in medical devices and/or manufacturing environment, in a Quality Engineering role or equivalent.
Primary Work Location
USA NJ - Delran
US BD 1st Shift 8am-5pm (United States of America)