BD is looking to resolve quality problems, improve areas of high-quality costs, and assist suppliers and subcontractors in meeting BD’s quality needs by hiring a Quality Engineer.
Requirements
- Experience in CAPA and root cause analysis
- Preferred Experience in validation and process controls
- Preferred FDA regulation experience
- Preferred Experience with ISO 13485 and 21CFR PART820
Responsibilities
- Design and conduct Quality Engineering studies to resolve causes of quality non-conformances, initiate changes in process, tooling, product design, etc. to correct them.
- Provide technical support to resolve quality problems in manufacturing or with suppliers as warranted.
- May perform qualification studies for new suppliers, components, and inspection test equipment.
- Plan and execute validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
- Provide documented instructions for performance of Q.C. Inspections, including Inspection plans, Test Procedures, and Quality Standards.
- Evaluate customer's specifications for BD’s ability to comply.
- Completes Material Review Notice (MRN). This includes maintaining database and reporting to management.
Other
- Bachelor’s Degree in Engineering field or 2 to 4 years QE Experience with a Bachelor’s Degree
- Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over sponsorship of employment Visa at this time.
- For most roles, we require a minimum of 4 days of in-office presence per week
- For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19.
