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.
HOURS: 7PM - 7AM
ESSENTIAL FUNCTIONS:
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.
REQUIREMENTS:
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
Physical Demands:
Physical demands include activities associated with working in a manufacturing and warehouse environment such as standing, walking, lifting up to 20 lbs.
Work Environment:
The work environment is fast-paced and primarily centered in busy manufacturing areas, with minimal time spent in an office setting. This position is an on-site position (not remote).
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
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 health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ