Jjmd Senior Source Quality Engineer (Ciudad Juárez)

Job Function

Quality

Job Sub Function

Supplier Quality

Job Category

Professional

All Job Posting Locations

Ciudad Juarez, Chihuahua, Mexico

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Purpose

The Site Senior Quality Source Engineer serves as the on-site Johnson & Johnson Medical Devices (JJMD) quality engineering representative for the Strategic Collaborator (SC). In collaboration with the SC, he/she utilizes quality engineering principles and problem‑solving skills to improve and maintain JJMD products and processes. He/she supports the SC quality engineering team on initiatives impacting JJMD products and processes, including validation, risk management, product quality issue resolution and escalation, and quality systems performance monitoring. The Senior Quality Source Engineer is responsible for ensuring that the SC has a clear understanding and ability to execute to the JJMD/SC Quality Agreement requirements, J&J; Policies, and applicable regulations and standards.

Duties & Responsibilities

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position

• Reviews and approves key quality records as they related to JJMD products such asSite Validation Master Plan. o Validation protocols and reports per Change Control Processes.
• High‑risk CAPAs (i.e., Field Action, External Observations)
• New or revised inspection plans and associated sampling strategies.
• Where necessary, collaborate with PSC in failure investigation and corrective action planning for High‑Risk CAPAs (i.e. Field Action, External Observations) involving JJMD products.
• Coordinates JJMD review and approval of.
• Non‑routine rework in collaboration with other required JJMD functions such as Design Quality, Product Management, and Sustaining Engineering.
• Use‑as‑Is Nonconformance Disposition in collaboration with other required JJMD functions such as Regulatory Affairs and Medical Affairs.
• Supports Technical Assessments in collaboration with SC site compliance, JJMD Supplier Quality Compliance, and JJMD Product Management.
• Partners with SC Quality Engineering, JJMD Medical Affairs, and JJMD R&D;/PM in the development of Process Failure Mode Effects Analyses (pFMEAs) and corresponding Control Plans.
• Partners with SC on Recall Prevention and External Audit Readiness initiatives.
• 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

• University/Bachelor’s Degree or Equivalent.
• Approximate experience, or equivalent, knowledge and skills, necessary to satisfactorily perform the position responsibilities.
• 4 - 6 Years with BS in Related Field.
• Experience working in both an FDA and European regulatory environment is preferred.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data and be able to present data that facilitates/drives decision making.
• The ability to perform "hands on" troubleshooting and problem solving is required.
• Good technical understanding of manufacturing equipment and processes is required.