Senior Quality Engineer (Temporary 12 months)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

Monitor all FGQA quality assurance functions.

Establish and maintain appropriate documentation as required for Quality Assurance activities and the Quality Documentation Systems.

Develop statistical sampling plans and perform process capability studies.

Implement process control systems and provide technical support for process validations.

Provide QS support in Product transfers and new products development.

Assist in training new engineers train technicians and supervisors in process changes.

Perform Complaint analysis investigation as needed.

Participate in process/ quality improvement projects.

Assist with implementation of EES applications for quality systems.

Support COGs initiatives.

Responsible for following and administering safety.

Compliance with safety policies and procedures.

Follow J&J and EES Records Management Policies for Convenience Information Records Retention Schedules Training and Education Document Hold Notices Records Cleanout Inactive Records and Information Management Vital Records and third-party vendor if applicable.

Follow J&J and EES Records Management Policies for Convenience Information Records Retention Schedules Training and Education Document Hold Notices Records Cleanout Inactive Records and Information Management Vital Records and third-party vendor if applicable.

Assist review & approve non-conformances investigations & non-conforming product dispositions.

Provide as needed subject matter expert feedback on manufacturing process changes. Other responsibilities may be assigned and not all responsibilities listed may be assigned.

Responsible for communicating business related issues or opportunities to next management level.

Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.

For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable.

Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.

Performs other duties assigned as needed

Qualifications / Requirements:

• Bachelor degree in engineering- mechanical electrical industrial preferred or Applicable science Extensive validation experience is critical

• Individual needs to be able to independently manage complex validations

• Bi-lingual Spanish/English

• CQE CRE CQA 2 Ratings GB preferred.

• Generally requires (4-6) years related experience

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Preferred Skills: