Job Description Summary
This position performs various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance/Document Control/Design Control. This includes working to support Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D/Product Development departments.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 DUTIES AND RESPONSIBILITIES: include the following. Other duties may be assigned.
Represents the Corporation, Business Unit and Quality Department in a professional manner.
Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required.
Creates and reviews Quality System Documents
Creates and reviews Product Documents
Creates and reviews Test Methods
Creates/reviews Protocols, Process and Product Validations, Stability Protocols
Provides work direction as required.
Creates and reviews documents required for Design History File.
Creates and reviews Risk Assessments such as FMEA, FMECA or FTA.
Performs Supplier Quality System Audits.
Ensures compliance to Department and Business Unit procedures.
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
Interfaces with manufacturing facility or other Business Unit Facilities.
Travels as required by the above duties and responsibilities.
QUALIFICATIONS:
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to perform detailed engineering work under direction of Quality Engineering Management. May require consultation and direction to complete the essential duties and responsibilities.
Understands basic applied statistics.
Knowledge of manufacturing processes.
Comprehensive knowledge of quality systems and relationship to business.
Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
Ability to participate on teams and maintain positive work environment with those teams.
Good communication skills (verbal, written, and presentation)
Understands Basic Fundamentals of Engineering Principles
Ability to effectively manage time
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications.
Ability to interpret Regulations, Corporate, Business Unit and Department Procedures.
EDUCATION and/or EXPERIENCE:
B.S. in Engineering, Engineering Technology, Science, or equivalent, at a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
Experience with FDA regulated industry, preferably on product development programs.
LANGUAGE SKILLS:
Ability to read and comprehend verbal and written instructions.
Ability to effectively present information in one-on-one and group situations to supervisor, management and other employees of the organization.
MATHEMATICAL SKILLS:
College level mathematical skills.
Basic applied statistics.
REASONING ABILITY:
Problems will be approached logically and methodically and be able to develop solutions and/or options.
Judgment must be made by considering a few important facts.
Written rules, precedents, and policies are available for guiding decisions, but are not always easily obtained.
Decisions are made frequently but are rarely needed immediately.
As Design Control/ECR work and/or other responsibilities increase, so do the level of complexity and the importance of decision-making.
PHYSICAL DEMANDS:
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
Office and manufacturing environments
Role is Hybrid (onsite 4 days a week, mandatory Monday-Thursday with Friday as a Work From Home day).
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 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.
Required Skills
Optional Skills
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Primary Work Location
USA GA - Covington BMDAdditional Locations
Work Shift
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ