Senior Quality Engineer

Becton Dickinson; Brea (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

BD is a leading medical technology company focused on turning health care into a better and more efficient experience. The Senior Quality Engineer will support new product development and product maintenance through quality engineering principles for medical devices, from inception through launch and ongoing maintenance.

The role involves leading design control, risk management, process validation, and CAPA activities, with emphasis on audits, regulatory compliance, and cross-functional

Qualifications

• 7+ years of relevant experience or equivalent education.
• 5+ years supporting design assurance for medical devices.
• Knowledge of 21 CFR 820, ISO 13485, MDR, ISO 14971, ISO 10993.
• ASQ certification desirable but not required.
• Design for Six Sigma preferred.

Responsibilities

• Mentors and coaches for application of quality principles and systems.
• Develops technical solutions for complex problems using quality tools.
• Leads design control / process control projects as core team member.
• Can serve as a CAPA expert.
• Supports quality system audits and management reviews.

Skills

Quality engineering

Statistics

Problem solving

Interpersonal skills

Leadership

Communication

Education

Bachelor's Degree

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

As directed by the Associate Director - Quality, the Senior Quality Engineer is accountable for supporting new product development and product maintenance through the application of Quality engineering skills for medical devices. This person will handle projects and tasks, from product inception through product launch and maintenance, and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Business Unit policies while meeting all design control and other regulatory requirements.

Responsibilities

• Provides support/mentoring/coaching for application of technical principles, theories, concepts and quality, tools and systems.
• Develops technical solutions to complex problems which require the regular use of technical knowledge, experience, ingenuity, and creativity.
• List a core team member for complex design control / process control projects.
• Can serve as a CAPA expert.
• Modifies methodologies and procedures, ensuring continuous improvement of desired outcomes.
• Supports quality system audits.
• Provides input to the management review process.
• May perform other duties as required.

Scope of Responsibilities

Develops advanced technological ideas and guides their development into a final product, process or business opportunity.

Ensures the accurate and actionable recording of data for the making of decisions as well as to document development work

Contributes to long-range business strategies, choosing disciplines and methods appropriate to the work content and context

Outputs contribute to reduced cycle times, improved effectiveness and furthering the achievement of goals critical to company objectives

Position-Specific Overview

Position specific responsibilities include support of the following, however, are not limited to:

• Design Control
• EU MDD/MDRl
• Change control
• Risk Management
• Process Validation
• Identification of CTQ's
• Handling of deviations and non-conformances
• Test method validations
• Supplier qualification
• Post Market Surveillance
• CAPA - Root cause investigation and implementation of corrective / preventive actions
• Proper Use of Statistics (Sampling Plans)
• Advise on Regulations and standards
• Liaise with Manufacturing Plants
• Provide functional support to cross-functional teams
• Support Internal and external audits

Sphere of Influence

Work is performed without appreciable direction. Assignments are often self-initiated. Determine and pursue courses of action necessary to obtain desired results. Plans and participates in disciplines strategically relevant to the business and/or functions Provides advice and mentors junior Associates Participates in, and may provide leadership for, multi-disciplinary projects Considered Site / functional level Subject Matter Expert. May be assigned as site / functional extended team member

Qualifications

• Bachelor's Degree
• A minimum of 7 years of relevant experience or a combination of equivalent education and relevant experience
• Minimum 5 years of experience supporting design assurance for medical devices
• Extensive knowledge of applicable regulatory, Corporate and/or Unit requirements. Applicable Regulatory and Industry standards (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971,ISO 10993, etc.)Quality Engineering tools, Statistics, Problem Solving, strong Interpersonal Skills, Leadership, all forms of Communication ASQ Certificate(s) desirable (but not required)
• Design for Six Sigma preferred

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to