Job Position Title:Manufacturing Quality Engineer

Function:Quality

Location:Columbus West

Job Group/Grade:     JG3

Position Summary:

Assist the Manufacturing Departments in the establishment and implementation of programs designed to assure control of processes and products toward established standards of quality.  Use problem solving techniques to increase quality and productivity within the business.Ensures compliance with BD quality systems, policies, procedures and best practices, and all local, state, federal and BD safety regulations, policies and procedures.  Regular, punctual attendance is an essential job function. Ability to write programs supporting the implementation of the eDHR project. Ability to read and write and converse in English.  Willing and able to uphold BD Values.

Duties/Responsibilities:

• 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.

• Moniitor 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.

• Develop 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 required to support the needs of the business

Education:

• Bachelor’s degree required

Experience:

• Three years manufacturing experience with broad background in manufacturing process

• Two years Process Control experience

• Three years practical GMP/Medical Devise manufacturing experience

• Validations experience, preferred.

Knowledge, Skills and Abilities:

• Effective Oral/written Communication - Proficient 

• Ability to work as part of a team / Teambuilding - Advanced

• Independent thinking / Self Driven - Proficient

• Decision Making Ability - Proficient 

• Computer Skills / Microsoft Office - Proficient

• eDHR related software.

• Product / process improvements utilizing Green/ Black Belt/Six Sigma techniques.

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

PCP Level:   N/A