Quality Engineer, Validation

BD•Grayson, GA

2d•Onsite

About The Position

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. Job Summary The Quality Engineer, Validation will be responsible for ensuring the quality and compliance of Becton, Dickinson and Company's products and processes through the development, execution, and review of validation activities. This role plays a critical part in maintaining regulatory adherence and product reliability across various stages of the product lifecycle.

Requirements

Bachelor's degree in Engineering (e.g., Biomedical, Mechanical, Electrical, Chemical) or a related scientific discipline.
Minimum of 3-5 years of experience in a Quality or Validation engineering role within a regulated industry, preferably medical devices or pharmaceuticals.
Strong understanding of GxP regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and industry validation standards.
Proven experience in developing, executing, and reviewing IQ, OQ, and PQ protocols and reports.
Proficiency in statistical analysis and data interpretation related to validation.
Excellent written and verbal communication skills with the ability to effectively present technical information.
Strong problem-solving and analytical skills with attention to detail.
Ability to work independently and as part of a cross-functional team in a fast-paced environment.

Nice To Haves

Experience with risk management methodologies (e.g., FMEA) is highly desirable.
ASQ certification (CQE, CQA, or CQV) is a plus.

Responsibilities

Develop, execute, and review validation protocols (IQ, OQ, PQ) for manufacturing equipment, processes, software, and test methods in accordance with company procedures and regulatory requirements (e.g., FDA, ISO).
Perform risk assessments and develop validation strategies to ensure appropriate controls are in place and documented.
Analyze validation data, generate comprehensive validation reports, and present findings to cross-functional teams.
Collaborate with R D, Manufacturing, Engineering, and Regulatory Affairs to define validation requirements and ensure successful implementation.
Investigate and resolve deviations, non-conformances, and CAPAs related to validation activities.
Participate in design reviews and provide input on validation considerations for new product development and changes to existing products.
Maintain and update validation master plans and schedules.
Support internal and external audits by providing validation documentation and subject matter expertise.
Identify and implement continuous improvement opportunities within the validation process.
Train and mentor junior engineers and technicians on validation principles and procedures.