About this Quality Assurance Lead- 4th Shift role at BD
We are the people who give possibilities purpose
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.
Job Description
Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
Quality Oversight & In-Process Activities
Perform in-process inspections, audits, sampling, and testing activities in accordance with approved procedures, specifications, and sampling plans.
Monitor manufacturing processes through routine quality audits and observations to verify compliance with approved procedures and quality requirements.
Conduct quality inspections using approved methods, equipment, and techniques.
Perform raw material inspections to verify compliance with established specifications.
Verify that finished products meet applicable specifications prior to release or disposition.
Ensure proper handling, identification, and traceability of materials, samples, and quality records throughout the manufacturing process.
Leadership & Training
Provide day-to-day guidance and technical support to Quality Assurance Technicians and designated manufacturing personnel.
Assist with onboarding and training of QA Technicians and production associates on quality requirements, inspection methods, sampling practices, GMP, GDP, and applicable procedures.
Support qualification and ongoing competency assessment of personnel performing quality-related activities.
Serve as a quality resource for manufacturing operations by promoting compliance and quality awareness.
Deviation Management, Investigations & Escalation
Identify, document, and escalate nonconformances (NCR(QNs)), deviations, and abnormal conditions through established quality systems.
Support containment, investigation, and disposition activities associated with nonconforming materials and products.
Collaborate with Manufacturing, Engineering, and other cross-functional teams to investigate quality issues and support root cause analysis.
Assist in implementation and follow-up of corrective and preventive actions intended to prevent recurrence of identified issues.
Provide timely communication and escalation of quality concerns to Quality leadership and impacted functions.
Quality Systems & Continuous Improvement
Support development, revision, implementation, and maintenance of quality procedures, work instructions, and forms.
Support compliance with Quality Management System requirements through audits, inspections, and routine monitoring activities.
Maintain accurate, complete, and contemporaneous quality records in accordance with Good Documentation Practices (GDP).
Support internal audits, external audits, regulatory inspections, and audit readiness activities.
Perform statistical analysis, trending, and evaluation of quality data to identify opportunities for improvement and communicate findings to management.
Prepare and maintain quality metrics, reports, and summaries as required
Compliance & Documentation
Ensure compliance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), company policies, and applicable regulatory requirements.
Execute activities in accordance with approved SOPs, Work Instructions, specifications, and quality standards.
Maintain required training qualifications and certifications.
Support data integrity, documentation accuracy, and record retention requirements.
Safety & Compliance
Demonstrate compliance with site safety requirements and actively support safety initiatives.
Maintain required safety training and certifications.
Adhere to all company policies and procedures.
Perform other duties as assigned to support business needs.
Education and Experience:
High School/GED or equivalent required.
Associate Degree or Technical Degree in a scientific, technical, or related discipline preferred.
3+ year of Quality Assurance experience, Preferred
Knowledge and Skills:
Ability to work independently with minimal supervision.
Working knowledge of cGMP, GDP, quality requirements, and applicable regulatory standards.
Experience enforcing SOPs, specifications, and quality requirements.
Proficiency in Microsoft Excel and basic data analysis.
Strong mathematical, analytical, and problem-solving skills.
Experience using measuring and inspection equipment.
Ability to review and complete documentation accurately and in compliance with established procedures.
Strong attention to detail, organizational skills, and communication skills.
Ability to identify, evaluate, and escalate quality issues as appropriate.
Physical Demands: (if applicable)
Ability to stand and walk for extended periods.
Ability to lift and carry materials as required by job duties.
Ability to perform routine physical activities associated with a manufacturing environment.
Work Environment: (if applicable)
Manufacturing. 4th Shift Monday - Two weekdays 6:00 am to 2:30 PM and Saturday - Sunday 6:00 AM to 6:30 PM
Why Join Us?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
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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