Quality Engineer

Job Description Summary

Supports manufacturing process risk identification, evaluation and mitigation for day-to-day operations, new product introduction and continuous improvement of the quality management system. This position handles multiple projects/programs while keeping to key deadlines.

Integrates knowledge of business and functional priorities to address complex problems and non-standard situations. Acts as a key contributor in a complex environment and works independently with minimal guidance.

Job Description

We are the makers of possible

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.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Responsible for product and service quality evaluation and control:

Works cross-functionally in the development and or maintenance of products and or services.

Supports equipment and process-related issues; activities including equipment, process, materials, and method validation as well as statistical analysis and metrics to analyze those systems and processes being measured.

Supports design control activities related to New Product Development and Sustaining Engineering. This includes risk management activities, MSAs, developing appraisal systems, component qualification and process validation activities.

Accountable for setting own work direction and completing work tasks.

May accomplish tasks through coaching and supervision of support and entry-level professional associates.

Applies statistics to make decisions.

Ability to make and present risk-based decisions

Prepares product and process reports by collecting, analyzing, and summarizing information and trends.

Lead / support external (supplied component) and internal (manufacturing process) validations and associated activities for new products, existing processes, changes and transfers as required.

Participate on project teams as a Core Team Member or Leader.

Representing manufacturing quality and / or quality processes.

Develop and implement new quality processes for production and scale-up programs and ensure successful quality goals.

Maintains a working knowledge of new methods, equipment, product specifications, waste, costs, through put rate, and material costs to be used in the justification of new equipment and cost reduction projects.

Prepares process descriptions and quality manufacturing specifications as required

Provides technical guidance as needed to manufacturing and hourly technical personnel during the start-up of new or changed products and processes.

Uses good decision making, problem solving and trouble-shooting techniques to minimize the potential or correct ongoing manufacturing quality issues.

Ability to develop and create procedures, work instructions, templates / forms

Initiates nonconformance reports when appropriate.

Supports investigations and continuous improvement activities.

Proposes improvements to processes and may be responsible for quality execution of a process or analysis.

Applies knowledge and skills to a variety of standard and nonstandard activities.

Works with minimal guidance in own area of knowledge.

Other duties as assigned.

Required Qualifications:

Demonstrates knowledge of process risk management activities and quality management systems.

Has knowledge and skills within the Quality Engineering Body of Knowledge.

Strong interpersonal skills.

Ability to create and provide training.

Problem solving ability.

Ability to create, review and coordinate test protocols and reports.

MS Word and Excel.

Minitab or equivalent.

Preferred Qualifications:

CQE, CSSBB

Experience leading / creating PFMEA and Control plans, applying knowledge of product, process, and observations from operators

ISO 13485

ISO 14971

12CRF820

Supplier / Quality System Auditing

PPAP

Education and/or Experience:

Bachelor of Science in an engineering degree.

Minimum of 3 years of related experience.

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?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.

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

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.

#earlycareer

Primary Work Location

USA CA – Irvine Neomend

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You (https://jobs.bd.com/benefits) .

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$99,000.00 – $163,300.00 USD Annual

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.