Senior Quality Engineer

BD, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people's health throughout the world. The Company has been instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 50,000 associates in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD is an Equal Opportunity/Affirmative Action Employer.
This role is in BD Diabetes Care (BDDC), which is one of the fastest growing and most patient-connected business units within the company. The BDDC business unit has a 92 year history within BD and is unique in that it focuses on one important disease state which is a threat to world health. The Diabetes Care (DC) business unit is comprised of approximately 1,850 associates globally. The growth strategy includes strengthening our leadership position in diabetes drug delivery devices, entering targeted adjacencies to satisfy significant unmet needs, and developing and commercializing transformation products designed to eradicate the complications associated with diabetes. The DC business unit is committed to easing the burden and making health care affordable for people living with diabetes worldwide.
Within the Diabetes Care business, you will have the opportunity to play a vital role in the Advanced Diabetes Care platform, make a key impact in the Diabetes Care market and be a key contributor to BD's future growth. You will also have the advantage of combining the best of both worlds; the agility and creativity of a start-up environment, and the backing and resources of a Fortune 500 company. We are looking for highly innovative, passionate, and talented individuals to develop these innovative products. If you're interested in being a part of developing and commercializing exciting, revolutionary products to for the Diabetes Care market, and with the goal of improving the lives of people with Diabetes, please read on.
As directed by the Quality Manager ? Plant, the Senior Quality Engineer is accountable for supporting for new product development, manufacturing, quality operations, and product maintenance for the Advanced Diabetes Care Platform through the application of Quality engineering skills for medical devices. This associate will handle projects and tasks with an emphasis on injection molding, from product inception through pilot manufacturing, product launch and post launch maintenance. The candidate will play an active role in the processes to ensure products meet quality standards consistent with both Corporate and Unit policies, while meeting all design control and other regulatory requirements.
The Senior Quality Engineer will work as a member of cross-functional project teams engaged in new product development and manufacturing for electrical, mechanical, and software driven medical devices. The individual will serve as a quality representative on project teams and will work closely with Operations, Procurement, Regulatory, Core Team Leader, R&D, Marketing, and Medical in addition to regulatory agencies and suppliers.
Support new product development projects following Design Control processes, responsibilities include supporting: molding qualification, metrology, incoming inspection, quality planning, engineering and clinical product builds, design verification & validation, design reviews, risk management, design transfer, and manufacturing control planning aspects of the project.
Support manufacturing processes, including computer-controlled high speed and/or manual and special processes such as sterilization and molding. Perform root cause analysis for manufacturing process deviations and develop corrective and preventive actions.
Support change management process by analyzing change impact to product or process, identifying supporting tasks, and ensuring completion of deliverables.
Perform inspection and test method development and validation. Develop quality plans for receiving, in-process and final inspection.
Perform process validation activities, including IQ, OQ, PQ, Software, capability analysis and DOE for automated manufacturing equipment.
Review molding qualifications and work with the molding suppliers to ensure product requirements are achieved.
Understanding and applying the Six Sigma methodology including Define, Measure, Analyze, Improve and Control and participate on improvement projects.
Support CAPA, non-conforming material handling, supplier management, complaint handling and procedure development.
Provide guidance to ensure that all activities performed are in accordance with Quality System and regulatory requirements.
Prepare technical documentation including plans, procedures and reports.
Support quality / regulatory audits and FDA inspections.
BS degree in engineering, technical, or science required. MS preferred.
A minimum of 5 years relevant technical experience or a combination of equivalent education and relevant technical experience.
Knowledge of 21CFR 820, ISO 13485, ISO 14971, MDD 93/42/EEC, design controls, and applicable medical device regulations.
Class II medical device experience, Class III preferred.
Thorough knowledge to support injection molding supplier quality projects and tasks for medical devices
Excellent communication, problem solving, organizational and interpersonal skills are essential.
Ability to work in teams to obtain results is required.
Effective skills in analytical thinking and problem solving is required.
Self-motivated and directed, requiring minimal supervision.
Experience leading others through process mapping exercises and problem solving.
Professional certifications (CQE, CQA, CRE, etc.) are preferred.
Knowledge of statistical methodologies and software tools are preferred.
Six sigma training and certification is desired.
Project management skills are desirable.
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.

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