QE Complaints

BD Mexico; Columbus (NE); On-site; USD 65,000 - 90,000; Full time

Job summary

BD is a leading global medical technology company. This role supports quality engineering in manufacturing, focusing on complaint handling, process control, and regulatory compliance.

You will partner with Process Engineering and Production, monitor trends, drive corrective actions, and help ensure safety, GMP, GDP compliance, and audit readiness. Bachelor's degree required and 2 years manufacturing experience preferred.

Qualifications

• 2 years manufacturing experience with broad background in manufacturing processes.
• Experience working in medical device manufacturing industry.
• Experience working with high performing work teams desired.

Responsibilities

• Good understanding of the manufacturing processes.
• Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address complaint issues.
• Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities and elimination of customer complaints.
• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality cost that are focus on eliminating customer complaints.
• Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.
• Own and continue to improve the complaint process
• Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface.
• Provide assistance and guidance on quality improvement.

Education

Bachelor degree

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

RESPONSIBILITY:

• Essential responsibilities include but are not limited to:
• Good understanding of the manufacturing processes.
• Process monitoring and adjustment, process improvement, and product improvement including corrective action plans to address complaint issues.
• Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities and elimination of customer complaints.
• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality cost that are focus on eliminating customer complaints.
• Assume a role of leadership in analyzing and resolving issues, which prevent desired quality levels achievement.
• Develop programs for the maintenance, replacement and improvement of inspection mechanism
• Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices.
• Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.
• Own and continue to improve the complaint process
• Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface.
• Provide assistance and guidance on quality improvement.
• Insure that all company safety rules and regulations are followed and promote general plant safety.
• Own and lead efforts to reduce and eliminate customer complaints.
• Assist in internal and external audits as needed.
• Communication to all levels.
• Other duties, as assigned

KNOWLEDGE AND EXPERIENCE

EDUCATION

• Bachelor degree required

EXPERIENCE

Preferred Experience

• 2 years manufacturing experience with broad background in manufacturing processes
• Experience working in medical device manufacturing industry
• Experience working with high performing work teams desired.

ACCOUNTABILITY:

• Expedient, accurate operation of quality engineering functions.
• Reports to the Associate Director.
• Manage priorities and sense of urgency.
• Has direct influence on product costs and expenditures as follows:
• Expedite processing of complaints.
• Meeting schedules on complaints investigation
• Responsible for designing controls to minimize product costs and eliminate risk of recalls and liability losses.
• Must obey all safety rules.
• Must follow all GMP and GDP (if applicable) rules.
• Must cooperate fully with the safety and environmental program.
• May not pose a direct threat or significant risk to himself/herself or others.
• The “Essential Function” and “Other Functions” listed in this description do not restrict the addition or deletion of any other responsibilities to this position.
• Management reserves the right to change any and all job descriptions without notice as business conditions dictate.

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 NE - Columbus (West)

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.