Quality System Specialist II

1000 Becton, Dickinson and Company; Sumter (SC); On-site; USD 55,000 - 75,000; Full time

Job summary

BD is a large global medical technology company focused on advancing health. The Quality System Specialist II supports FDA and ISO compliance, manages CAPA and internal audits, and drives corrective/preventive actions across the plant.

The role involves handling customer complaints, root cause analysis, data trending, and training to maintain high quality standards. The position reports to the Quality Manager, Quality Systems, and emphasizes a strong compliance culture with opportunities to

Qualifications

• High School Diploma or GED required with 2-3 years related work experience preferred.
• Experience with FDA and ISO compliance is a plus.
• Knowledge of CAPA, audits and quality systems.

Responsibilities

• Evaluate customer complaints and lead investigations to identify root causes.
• Analyze complaint data and identify trends and chronic issues.
• Document all activities related to complaint analysis, CAPA and investigation.
• Handle returned samples safely and dispose of contaminated items.
• Audit corrective actions for effectiveness.
• Participate in internal/external audits and report findings.
• Conduct quality training to ensure regulatory compliance.
• Manage the plant CAPA system to ensure accuracy of procedures.
• Manage the internal audit program to ensure regulatory compliance.
• Plan and perform plant system audits and coordinate audit teams.
• Conduct supplier audits to ensure QSR/ISO compliance as directed.

Skills

Root cause analysis

CAPA management

Internal audits

FDA compliance

ISO compliance

Documentation

Quality training

Problem solving

Education

High School Diploma or GED

Tools

QMS

Job description

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

The Quality System Specialist II is responsible for management of the plant’s corrective/preventive actions, internal audits system, customer complaints and other activities related to FDA and ISO compliance as assigned. Supports the plant in identification and resolution of quality assurance and regulatory issues related to product lines to assure compliance with FDA regulations, ISO standards, Corporate directives and company strategies. Reports directly to the Quality Manager, Quality Systems.

ESSENTIAL FUNCTIONS

• 1. Evaluates customer complaints, including the coordination of documentation review, sample testing, and root cause analysis. Leads and/or facilitates the compliant investigation to reduce or eliminate causes of the complaints.
• 2. Analyzes complaint data and reports trends and triggers for significant complaint issues. Trends complaint data to identify significant changes and identifies chronic complaint categories.
• 3. Documents all activities related to complaint analysis, failure investigation, corrective action, preventive action, and effectiveness. Maintains customer complaint related files per policy/procedures.
• 4. Handles returned samples in a safe manner, taking all necessary precautions related to contaminated and ‘sharp’ products.
• 5. Audits corrective actions implemented to remedy complaints for effectiveness.
• 6. May participate in the site’s internal / external auditing function, developing audit reports and communicate them to auditees and the quality group.
• 7. Conducts quality training as required to ensure compliance with Federal Regulations and International Standards where appropriate.
• 8. Manages the plant’s corrective/preventive action system as assigned to assure consistency and accuracy of specifications and procedures necessary to manufacture products of the highest quality and compliance to regulatory and company requirements. Performs the Site CAPA Leader responsibilities as defined in established procedures.
• 9. Manages the plant internal audit program as assigned to ensure compliance to Federal Regulations and International Standards as required.
• 10. Plans and performs intensive audits of the plant systems and procedures in accordance with established procedures. Coordinates plant audit teams to include training, scheduling, performing, and reporting of audit as necessary.
• 11. Conducts supplier audits to ensure compliance with QSR/ISO as directed by material requirements and company guidelines.

Minimum Requirement: High School Diploma or GED 2-3 years related work experience preferred

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 . Primary Work Location USA SC - Sumter Additional Locations Work Shift PR 800am-500pm M-F (United States of America)

We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible.

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.

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.