Quality System Specialist II

BD; Sumter (SC); On-site; USD 70,000 - 80,000; Full time

Job summary

BD is a leading global medical technology company focused on advancing health through innovative solutions. The Quality System Specialist II will manage corrective/preventive actions, internal audits, and customer complaints to ensure FDA and ISO compliance across the plant's operations.

Reporting to the Quality Manager, Quality Systems, you will lead investigations, analyze trends, and coordinate CAPA activities to sustain high-quality production and regulatory alignment.

Qualifications

• High School Diploma or GED required.
• 2-3 years related work experience preferred.
• Experience with quality systems and regulatory requirements is desirable.

Responsibilities

• Leads and facilitates investigations of customer complaints and captures root cause analysis.
• Analyzes complaint data and tracks trends to identify significant changes.
• Documents CAPA activities and maintains files per procedures.
• Performs internal and external audits and supports audit reporting.
• Coordinates corrective and preventive actions to ensure effectiveness.
• Participates in site quality training and regulatory compliance activities.
• Manages the plant's CAPA system to ensure accuracy of specifications and procedures.
• Supports regulatory and corporate directives related to FDA/ISO standards.

Skills

CAPA leadership

Audit coordination

Root cause analysis

Regulatory compliance

Education

High School Diploma or GED

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

• 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.
• Analyzes complaint data and reports trends and triggers for significant complaint issues. Trends complaint data to identify significant changes and identifies chronic complaint categories.
• Documents all activities related to complaint analysis, failure investigation, corrective action, preventive action, and effectiveness. Maintains customer complaint related files per policy/procedures.
• Handles returned samples in a safe manner, taking all necessary precautions related to contaminated and ‘sharp’ products.
• Audits corrective actions implemented to remedy complaints for effectiveness.
• May participate in the site’s internal / external auditing function, developing audit reports and communicate them to auditees and the quality group.
• Conducts quality training as required to ensure compliance with Federal Regulations and International Standards where appropriate.
• 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.
• Manages the plant internal audit program as assigned to ensure compliance to Federal Regulations and International Standards as required.
• 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.
• 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.

Primary Work Location

USA SC - Sumter

Work Shift

PR 800am-500pm M-F (United States of America)