Sr Quality Engineer - Woburn, MA
Job Description SummaryBe part of something bigger!
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.
As Senior Quality Engineer, you 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.
Senior Quality Engineer - Woburn, MA
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. Master’s Degree preferred.
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.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
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 LocationUSA MA - Woburn
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Approbationdu Présiden et Chef de la direction
«Nous sommes une entreprise qui vise des résultats concrets et où nos associés s’emploient chaque jour à améliorer les soins de santé. De nombreuses initiatives sont en cours pour faire de BD un leader mondial des technologies médicales.»
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