Senior Quality Engineer

BD; Brea (CA); On-site; USD 106,000 - 169,000; Full time

Job summary

BD in the United States (CA, Brea) seeks a Senior Quality Engineer to support new product development and product maintenance within medical devices. You will apply quality engineering skills to ensure design control and regulatory compliance across product lifecycles.

Responsibilities include mentoring teams, guiding CAPA actions, improving methodologies, and participating in management reviews. This role requires collaboration across functions and potential audits.

Qualifications

• Bachelor’s degree required.
• 7+ years relevant experience in medical devices.
• 5+ years of experience supporting design assurance for medical devices.
• Regulatory and industry standards knowledge: 21-CFR-820, ISO 13485, MDD/MDR, ISO 14971, ISO 10993.

Responsibilities

• Provides support/mentoring for quality principles and systems; can serve as a CAPA expert on complex design control / process control projects.
• 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.

Skills

Quality engineering tools

Statistics

Problem solving

Interpersonal skills

Leadership

Communication

Education

Bachelor's Degree

Tools

ASQ Certificates

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

• 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

Primary Work Location

USA CA – Brea

Additional Locations

USA CA - San Diego Bldg A&B

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.

Benefits may include:

Health & Well-being: Medical, dental, vision, health savings and flexible spending accounts, life and disability insurance, wellness resources, mental health support, and disease management programs.

Retirement & Financial Well-being: 401(k), deferred compensation programs, financial counseling, DailyPay, and educational savings resources.

Work-Life Balance & Family Support: Paid time off, company holidays, educational assistance, parental leave, adoption assistance, backup care, caregiving support, employee assistance programs, commuter benefits, pet insurance, legal services, and associate discount programs.

Leave Programs: Bereavement, military, personal, family and medical leave, and jury duty leave.

Additional details regarding benefits and well‑being programs can be found in Our Commitment to You.

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

$105,500.00 - $168,800.00 USD Annual

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

To learn more about BD visit https://bd.com/careers.