Senior Quality Engineer

Becton, Dickinson and Company; Brea (CA); On-site; USD 106,000 - 169,000; Full time

Benefits offered by this job

Health & Well‑being benefits

Retirement & financial well‑being

Work‑Life Balance & Family Support

Leave Programs

Job summary

Becton, Dickinson and Company is seeking a Senior Quality Engineer to support new product development and product maintenance for medical devices. The role spans from product inception to launch, ensuring adherence to design controls and regulatory requirements. Collaboration across functions and mentoring of teams are key aspects.

Location is USA, CA – Brea, with additional San Diego presence. A strong background in quality systems, CAPA, risk management, and regulatory knowledge is required,

Qualifications

• Bachelor’s degree required in a relevant field.
• Minimum 7 years of relevant experience in medical devices.
• Minimum 5 years of experience supporting design assurance for medical devices.
• Extensive knowledge of regulatory and industry standards (21-CFR-820, ISO 13485, MDR, MDD, ISO 14971, ISO 10993).

Responsibilities

• Support/mentoring for application of quality engineering principles.
• Develop technical solutions for complex problems requiring ingenuity.
• Lead complex design control/process control projects.
• Act as CAPA expert and drive corrective/preventive actions.
• Support quality system audits and management reviews.
• Provide input to cross-functional teams and site leadership.

Skills

Quality engineering

Regulatory knowledge

CAPA

Design control

Risk management

Data analysis

Leadership

Problem solving

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

• 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

Location and Work Schedule

• 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

• 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.

Salary Range Information

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.

Health and Compliance

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.

Equal Opportunity

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.

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.

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 help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success.

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real‑life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.