JOB DESCRIPTION SUMMARY

The Quality Manufacturing Representative plays a critical role in ensuring that manufacturing operations consistently meet quality system requirements, product standards, and regulatory compliance. This position is responsible for reviewing documentation, releasing product for sterilization and shipping, and proactively collaborating with manufacturing teams to uphold quality standards on the production floor. The representative provides training, guidance, and input on quality issues while conducting audits to ensure adherence to policies and procedures. Additionally, they will support continuous improvement initiatives and assist Quality Engineers with resolving quality-related challenges. This role reports directly to the Quality Manager.

JOB DESCRIPTION

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 Manufacturing Representative plays a critical role in ensuring that manufacturing operations consistently meet quality system requirements, product standards, and regulatory compliance. This position is responsible for reviewing documentation, releasing product for sterilization and shipping, and proactively collaborating with manufacturing teams to uphold quality standards on the production floor. The representative provides training, guidance, and input on quality issues while conducting audits to ensure adherence to policies and procedures. Additionally, they will support continuous improvement initiatives and assist Quality Engineers with resolving quality-related challenges. This role reports directly to the Quality Manager.

EDUCATION:

• Required / Minimum: High School Diploma/GED

EXPERIENCE:

• Minimum of 1 year in a medical device manufacturing or similar experience.

KNOWLEDGE AND SKILLS

• Strong understanding of quality control principles and manufacturing processes.
• Knowledge of FDA regulations, GMP, ISO, OSHA and other applicable regulations required
• Proactively identify tasks and take action without prompting
• Experience with process control and root cause analysis.
• Meticulous attention to detail and commitment to maintaining high-quality standards.
• Strategically arrange tasks to align with priority and scheduled timelines
• Excellent problem-solving and analytical skills.
• Strong communication and interpersonal skills to work effectively with teams.
• Ability to interpret technical drawings and specifications.
• Ability to work overtime as necessary

COMPUTER SKILLS:

• Required: Microsoft Office Suite
• Preferred: SAP

• Partner closely with manufacturing teams on the production floor to monitor processes, ensure adherence to quality standards, and promptly address any quality concerns.
• Conduct routine product and process audits to ensure compliance with the quality system, actively engaging with manufacturing personnel to maintain high standards.
• Maintain accurate documentation of all inspections, audits, and findings, ensuring proper reporting and tracking of quality metrics.
• Ensure manufacturing associates receive ongoing support and coaching to continuously improve quality control methods.
• Act as a point of contact for resolving manufacturing quality issues, collaborating directly with operators and supervisors to drive corrective actions.
• Assist in training manufacturing associates on proper inspection techniques, good manufacturing practices, and compliance requirements.
• Apply and interpret ANSI Z1.4 and other sampling plans to predict defect rates and determine lot acceptance criteria.
• Support continuous improvement initiatives and contribute ideas to enhance production efficiency and quality performance.
• Perform thorough reviews of manufacturing documentation and release products to the next stage of manufacturing or shipping.
• Serve as a liaison between Quality Assurance (QA) teams and manufacturing personnel, ensuring seamless communication and timely resolution of quality concerns
• Uphold a clean and safe work environment while holding self and others accountable for following all safety policies and procedures.
• Perform all other miscellaneous duties as directed by Quality Management.