Job Opening: Quality Engineer II (Validation Engineer) Becton, Dickinson and Company: Moncks Corner
This position as Quality Engineer II (QEII) 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).
This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2022.
Provide leadership and support for quality objectives and process improvement efforts, serving as designee for the QA Ops Manager, as necessary.
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
Proficiency in variety of MicroSoft 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).
2 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
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA SC - Moncks Corner