BD (Tissuemed Ltd) · 5 days ago
Quality Engineer, Validation
Grayson, GA
Full-time
Onsite
Mid Level
3+ years expBD is one of the largest global medical technology companies in the world, focused on advancing health through innovative solutions. The Quality Engineer, Validation will ensure the quality and compliance of products and processes by developing and executing validation activities, maintaining regulatory adherence, and collaborating with cross-functional teams throughout the product lifecycle.
Health CareHospitalMedicalMedical Device
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
Qualification
Required
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
Preferred
Experience with risk management methodologies (e.g., FMEA) is highly desirable
ASQ certification (CQE, CQA, or CQV) is a plus
Company
BD (Tissuemed Ltd)
Experts in bioadhesives: Tissuemed develops and markets adhesive films to prevent air, blood and fluid leaks encountered in surgery.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$0.05M2021-12-09Acquired
2015-06-01Grant· $0.05M
Recent News
2025-02-21
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