The Quality Engineer performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance. The role provides guidance for the various elements of the Quality System, for example, to ensure process control and identifies/recommends opportunities for continuous improvement (internal/external). Applies the appropriate statistical tools to analyze data, identify root cause and corrective actions for effective problem resolution of small to moderate in scope and complexity. May support both internal and external audits.
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.
Key Responsibilities
Work with manufacturing engineers to solve problems that arise leading up to production
Acts as a resource to work groups and project teams, within the plant and outside the plant relative to quality
Maintains familiarity with manufacturing processes and products to evaluate the cause and effect of defects and identify trends in process and product quality.
Provides quality engineering project support with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, control plans, risk mitigation and other process improvement tools.
Conduct quality engineering investigations, calculations and preparing reports for out of tolerance conditions
Provides input to Test Methods and addresses Test Method Validation
Provides guidance to test technicians/quality inspectors as required
Provides assistance with internal and external quality system audits as a means of evaluating the effectiveness of the established Quality System and Good manufacturing Practices.
Provides technical guidance for projects using the application of FMEA's, risk mitigation, plant validations; DOE's' and other experiments and investigations as assigned.
Formulates, reviews and implements policies and procedures relating to product quality and process control as appropriate.
Coordinates communication between Division R&D and Plant personnel on new products, product improvements and product issues.
Monitor the performance of assigned product lines about product quality levels, waste, and rejection rates.
Own and lead efforts to reduce and eliminate rejections.
Assist in internal/ external audits as needed.
Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost.
Process monitoring and adjustment, process and product improvement, including corrective action plans to address complaint issues.
Supports and assures appropriate CAPA activities to accomplish internal/external objectives.
Assists with the investigation and closure of applicable Non-Conforming Material Reports
Support the implementation of new processes and automation projects to the manufacturing floor.
Support and recommend the disposition of all non-conforming products.
Other duties as required.
Educational Qualifications & Previous Experience
B.S. or B.A. Degree in Science-related field, Quality Assurance, Engineering, Mathematics/Statistics or equivalent.
Knowledge of QSR's/ISO 13485 and their application would be a plus.
A minimum of 1 year of experience in a manufacturing environment of related industry
Professional Skills & Key Competencies
Knowledge of electronics assembly and test
Ability to provide support to internal / external audits.
Ability to work in a fast-paced warehouse environment.
Desired / Additional Skills & Knowledge
Majority of time is spent working in a manufacturing environment
Ability to be able to work with limited supervision.
Solid understanding of Validations, IQ, OQ, PQ, and DOE's is desirable.
Class II / III medical device experience (preferred).
Knowledge of design control principles (preferred).
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.
