Senior Quality Engineer

Becton Dickinson Medical Devices•Brea, CA

8d•Onsite

About The Position

The Senior Quality Engineer supports medical-device new product development and product maintenance by applying quality engineering expertise. As directed by the Associate Director - Quality, this person handles work from product inception through launch and maintenance, helping ensure products meet quality standards, company policies, design controls, and regulatory requirements. The role develops technical solutions to complex problems, contributes to continuous improvement, and supports cross-functional projects and quality-system activities. The position works with limited direction, may initiate assignments, and determines courses of action needed to achieve results. It contributes to business strategies and objectives, mentors junior associates, and may lead multidisciplinary projects. The Senior Quality Engineer is considered a site- or functional-level subject matter expert. BD emphasizes in-person collaboration. Most roles require at least four days in the office each week; remote or field-based arrangements are indicated separately. The primary work location is Brea, California, with additional locations in San Diego, California.

Requirements

Bachelor’s degree.
At least 7 years of relevant experience, or a combination of equivalent education and relevant experience.
At least 5 years of experience supporting design assurance for medical devices.
Extensive knowledge of applicable regulatory, Corporate, and/or Unit requirements.
Knowledge of applicable regulatory and industry standards, including 21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, and ISO 10993.
Knowledge of quality engineering tools, statistics, and problem-solving.
Strong interpersonal, leadership, and communication skills.

Nice To Haves

ASQ certificates are desirable but not required.
Design for Six Sigma is preferred.

Responsibilities

Support new product development and product maintenance from product inception through product launch and maintenance.
Apply quality engineering principles, tools, and systems, and support or mentor others in their application.
Develop technical solutions to complex problems using technical knowledge, experience, ingenuity, and creativity.
Serve as a core team member for complex design-control and process-control projects.
Serve as a CAPA expert when appropriate.
Modify methodologies and procedures to continuously improve outcomes.
Support quality-system audits and provide input to the management review process.
Support design control, EU MDD/MDR, change control, risk management, process validation, identification of CTQs, deviations and non-conformances, test method validations, supplier qualification, and post-market surveillance.
Investigate root causes and implement corrective and preventive actions.
Apply statistics appropriately, including sampling plans, and advise on regulations and standards.
Liaise with manufacturing plants and provide functional support to cross-functional teams.
Support internal and external audits.
Ensure data is recorded accurately and actionably for decision-making and documentation of development work.
Contribute to long-range business strategies and select disciplines and methods appropriate to the work.
Advise and mentor junior associates, and participate in or provide leadership for multidisciplinary projects.
Perform other duties as required.