Quality Engineer at Becton Dickinson NA in Irvine, California

Job Description:

Job Description Summary




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.



ESSENTIAL FUNCTIONS OF THE POSITION

• Reviews inspection criteria, inspection methods and procedures to assure acceptable quality standards that meet the needs of the business.


• Provides technical and quality support to suppliers, the Manufacturing Engineering group and to the Customer Service department on the analysis of product returned from the field.


• Investigates product complaints and directs the activities required to assure the timely implementation and documentation of corrective action.


• Provides support and assures QSR compliance in product and process validations and product and process transfers.


• Monitors quality trends and conducts technical and statistical investigations on quality problems, reporting the results and recommendations in a timely manner.


• Prepares for and participates in internal and external audits and implements corrective action to audit observations to prevent recurrence.


• Participates in the Material Review Board meetings and takes the lead with other functional groups to determine root cause failure and implement actions to prevent recurrence.


• Supports operational teams responsible for investigating and providing corrective action for NCRs and/or CAPAs.


• Serves as Quality representative for design transfers or technology transfers.


• Lead the development of Process FMEAs.


• Leads Quality Engineering Projects to improve Quality System and Procedures (e.g., defect analysis, control charts, data analysis, lead Quality and Continuous Improvement Projects).


• Develops or assists in the development of Process Validation documentation such as protocols and reports (IQ, OQ, PQ) and performs statistical analysis as required.


• Performs test method validations to ensure accuracy, precision, selectivity, sensitivity, stability, and reproducibility of analytical or physical test methods used to assess the safety and efficacy of devices.


• Performs special projects and other duties as assigned.

QUALIFICATION GUIDELINES

• B.S. Degree in Engineering or Technical Science.


• Prior experience as a quality engineer lead on new product development teams.


• Relevant medical device experience.


• Applied Knowledge of the requirements of FDA QSR, ISO13485 and ISO 14971:2012.


• Experience in Quality Engineering disciplines including product/ process validation, applied statistics, and technical problem solving.


• ASQ CQE certification preferred.


• Experience with combination products and absorbable technologies preferred.


• A high level of competence in Quality Technology, statistical techniques, and six sigma tools including: sampling plans, process capability analysis, gage R&R, hypothesis testing, analysis of variance, regression, and design of experiments.


• Excellent problem solving, interpersonal communication, presentation, statistical analytical, computer, and project management skills


• Must have a positive attitude with excellent communication, negotiation and interpersonal skills to maintain a team oriented environment and maintain critical relationships with contractors, suppliers and investors.


• Ability to thrive under challenging deadlines and in an energetic environment.


• Must have a desire for achieving excellence in customer satisfaction, process and product quality and reliability.


• Ability to manage multiple projects, communicate updates, and meet milestones in a timely fashion.

WORK ENVIRONMENT / DEMANDS OF THE POSITION

• 
  Travel - Approximately 5% of work time will be spent traveling.


• 
  Physical Demand - The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, and sit for extended periods of time. Occasionally the employee will be required to lift or move at least 50 pounds.


• 
  Mental Demand - Moderate to high degree of concentration due to volume, complexity, and/or "pressure" of work. Expected to meet project deliverables that may require significant time commitments and support.

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?



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.


Required Skills


Optional Skills


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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 .


Salary or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.



Salary Range Information

$102,000.00 - $168,200.00 USD Annual Apply Now