BD (Becton, Dickinson and Company) Sr. Quality Engineer in Woburn, Massachusetts
Category: Medical Device / Quality Engineering
Job ID: 2018-11674
Career Level: experienced
Division: BDI Surgery - Woburn
Location: Woburn,Massachusetts,United States
BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties.
Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company.
BDI Surgery's Woburn, Massachusetts manufacturing facility manufactures hemostasis products, hernia and abdominal wall repair products. The facility also manufactures biological odor eliminators and creams/gels for BDI Interventional's Urology & Critical Care business unit, which is used primarily in hospitals and nursing homes.
Summary of Position with General Responsibilities:
This position will serve as the Quality Engineering lead for the Woburn Manufacturing facility. The primary responsibilities center on resolving manufacturing issues by implementing effective solutions, revising facility documentation for accuracy and compliance, validating equipment/processes/product as needed, and identifying/implementing continuous improvement projects.
Essential job Functions:
Oversee the Material Review Board (MRB), which includes providing leadership and coordination of activities for the investigation and disposition of non-conforming product and/or components
Identify and resolve issues in the manufacturing of Class III PMA medical device products, by designing and conducting Quality Engineering investigations, and working directly with manufacturing engineering, operators, and other plant personnel
Provide technical guidance to the staff and mentorship to quality and manufacturing engineers
Document risk-based rationales as needed throughout the Quality Management System
Write and execute validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
Manage CAPAs and Audit Action Plans to completion using risk analysis, project management, and proper effectiveness verification methods.
Revise procedures as needed based on nonconforming material investigations, CAPA, complaints, continuous improvement projects (CIP), and compliance to local, division, and corporate procedures, in addition to local and international quality regulations.
Represent the Quality function on committees, teams, task forces as assigned
Support the goals of the Quality Control Dept. and the Woburn Manufacturing facility
Special projects as assigned
Bachelor’s Degree in technical area
Minimum 5 years within medical device industry, preferably in Class II/III manufacturing environment
High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, process capability, process/equipment validation, Gage R&R, design of experiments, correlation and regression, analysis of variance, probability, etc.
ASQ Certified Quality Engineer and/or Six Sigma Black Belt strongly preferred
Strong statistical software and MS Project skills
Strong oral and written communication skills
Ability to motivate people and mentor engineers
Understanding of ISO 13485, MDD/MDR, GMP, QSR, and other applicable regulations, and the ability to interpret these as they apply to company issues
Strong project planning skills focused on meeting customer needs
Proven leadership skills in a fast paced environment
Additional Desirable Qualifications Skills and Knowledge:
- Master’s Degree 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