Job Description Summary

Job Description

How about becoming a maker of possible?

For more than 125 years, we’ve pursued our Purpose of advancing the world of health™. We relentlessly commit to a promising future by developing innovative technologies, services and solutions, helping the healthcare community improve safety and increase efficiency. It takes the imagination and passion of all of us at BD, from the manufacturing to marketing of our products, to look at the impossible and find transformative solutions to turn dreams into possibilities – For people today, tomorrow and beyond. Become a maker of possible with us!

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
 Represents the Corporation, Division, Facility and Quality Department in a professional manner.
 Manage and supervision of an engineering team to assure proper implementation of Quality Inspection &
Testing, Quality Engineering and Environmental Monitoring duties and responsibilities.
 Prepare and maintain department budgets.

 Hire, train, develop, review and manage exempt and non-exempt employees.
 Provide Quality Engineering support to assist to resolve quality issues.
 Prepare and implement the master validation plan.
 Prepare and implement the environmental monitoring activities.
 Prepare and implement facility policies and procedures related to quality.
 Create, review and approve Quality System documents.
 Create, review and approve protocols and summary reports.
 Create, review and approve required documents for Device History File.
 Develop, implement and maintain a risk management system in compliance with ISO 14971.
 Create, review and approve Risk Assessments such as FMEA, FMECA or FTA.
 Perform failure investigations and implement comprehensive corrective and preventive action plans.
 Analyze process and product non-conformances and implement comprehensive corrective and preventive
action plans.
 Perform Internal or Supplier Quality System Audits.
 Assure compliance of Corporate, Division, Facility and Department Standards, Procedur es and Policies
and design control procedures.
 Tracking and trending of Quality Indicators. Develop Quality Indicators to enhance quality of products and
business performance.
 Participate in the implementation of Lean–Six Sigma.
 Participate in personnel training in the use of JD Edwards and develop Power Users and troubleshooters.
 Active participation in transfer projects.
 Develop strategies for the development and growth of his/her direct personnel.
Education and Experience:
Bachelor of Science in Mechanical, Industrial or similar engineering field, or in other pertinent science or
technical field preferably.
Advanced degrees in Business Management or technical disciplines are also desirable.
American Society of Quality (ASQ ) Certified Manager of Quality/Organizational Excellence (CMQ/OE),
Certified Quality Engineer (CQE) and/or Certified Quality Auditor (CQA) also highly desirable.
Certified Six-Sigma Black Belt (SSBB) is desirable.
The ideal candidate would have 10 years’ experience in a manufacturing environment, with a minimum of 5
years in the quality/regulatory field with a medical device (FDA regulated) firm.
Experience with supervision of technical professionals is highly desirable. This is a middle management
position involving the supervision of a large team, composed of either technical or professional employees.

Language Skills:

Advanced

“BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity or sexual orientation.”

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

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