BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

This position as Quality Engineer assists with implementing and maintaining the effectiveness of the Quality System.  This position performs various quality-engineering functions and associated support tasks in driving business objectives, developing knowledge and experience in the areas of 21 CFR 820 and 803, ISO 9001-13485, and MDD.  This includes working to support Design Control projects as well as other duties in support of the Quality System, Document Control, Manufacturing department, and Investigations (CAPA, Complaints, Nonconformance, and Unscheduled Maintenance).

Job Duties/Responsibilities

• Provide leadership and support for quality objectives and process improvement efforts

• Coordinates and is accountable for overall compliance administration activities relating to QSR, Design Controls, Validations/Qualifications, and CAPA.

• Lead, own, and/or provide guidance/mentoring for investigations (investigations pertaining to CAPA, Audit response(s), DMAIC/Failure Investigations, etc.).

• Identify, implement, and supervise procedures and systems to support 21CFR§820, ISO 13485, and the European Medical Device Directive.

• Creates/reviews Protocols, Process and Product Validations, and Test Methods.

• Creates and reviews Risk Assessments such as FMEA and/or FTA.

• Other duties as assigned

Qualifications

• Proficiency in variety of Micro Soft applications including Word, Excel, Visio, Powerpoint, and Minitab or applicable software.

• Experience working with regulatory and statutory agencies (FDA, Notified Bodies, etc.).

• Experience working with Lean and Six Sigma methodologies.

• Demonstrated time management skills.

• Ability to translate quality requirements into product specifications.

• Ability to interpret Regulations, Corporate, Division and Department Procedures.

Education and Experience

• BA/BS in a scientific field (Engineering, Engineering Technology, Chemical/Biological or equivalent). 

• 3 years of medical device /pharmaceutical validation, CAPA, complaint investigation, or quality system auditing experience in a regulated industry.

• Proven knowledge and experience in problem solving, validations, CAPA, and investigations (Failure, DMAIC, complaint, etc.).

• Proficiency in Microsoft Word, Access and Excel

• ASQ certification (CQE, CQA, etc…) preferred.