Job Description Summary

GENERAL FUNCTION:
To assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality.
To use problem solving techniques to increase quality and productivity within the business.

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. 

JG 3

PCP Level- NA

Responsibility:

• Crucial responsibilities include but are not limited to:

• Develop, change, and supervise in-process inspections to ensure the greatest value in process control for the customer and the plant during the manufacturing process while meeting regulatory requirements.

• Process monitoring and adjustment, process and product improvement, including corrective action plans to address complaint issues.

• Documentation of these activities along with the review and maintenance of S.O., O.I.s and department specific operating procedures such as manufacturing cleaning procedures.

• Employee training of Quality Control concerns regarding Process specifications.

• Develop and implement procedures applicable to the total plant manufacturing process.

• Coordinate efforts with Process Engineering, Production for the establishment of controls, which support current product designs, and process capabilities for assigned product lines. Assistance in such areas as process validation, process acceptance, certain audit correction actions, Change Control issuance for process changes.

• Support CAPAs as owner or as part of the support team.

• Monitor the performance of assigned product lines about product quality levels, waste, and rejection rates.

• Leading / mentoring / conducting quality improvement projects thru CI initiatives.

• May acquire Green/Black Belt Certification.

• Assist in the acceptance and validation of process / equipment.

• Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost.

• 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 gauging.

• 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 department training systems.

• Monitor customer complaints and trends. Respond as needed for specific corrective action and customer interface.

• Provide support and guidance on quality/ process improvements.

• Ensure that all company safety rules and regulations are followed and promote general plant safety.

• Own and lead efforts to reduce and eliminate rejections.

• Assist in internal/ external audits and supplier certification processes as needed.

• Other duties, as assigned

Indirect supervision

• Supervision of QC Representatives & other support personnel necessary for assigned project completion.

EDUCATION

• Required: Bachelor of Science degree.

Experience

Required: 3 years manufacturing experience with broad background in manufacturing processes

• 2 years Process Control experience

• 2 years Quality manufacturing experience

• Proven history of product / process improvements utilizing Green/ Black Belt/Six Sigma techniques.

• Ability to generate validation protocols, which align with the globalization standardization initiative.

• Experience working with high performing work teams desired

• 3 years practical GMP / Medical Device manufacturing experience.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fu