Senior Supplier Quality Engineer

Johnson & Johnson Innovative Medicine•Cincinnati, OH

1d•$79,000 - $127,650

About The Position

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com 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. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech We are searching for the best talent for Senior Supplier Quality Engineer to be located in Cincinnati, OH. The Supplier Quality Engineers are responsible for supplier-related quality engineering activities in support of New Product Development and ongoing manufacturing. Supplier Quality Engineers have the opportunity to support activities associated with External Manufacturers, Direct Material (Component) Suppliers, and Indirect Service Suppliers. You will be responsible for: Issues resolution with suppliers – investigating challenging issues with significant business impact. Developing and maintaining suppliers – executing Supplier Reviews, audit related activities and deep dive Technical Assessments at suppliers. Development/negotiation of Quality Agreements with suppliers. Changing the way we do business – continuously improving our policies and procedures. Supplier process changes – assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities). Stabilizing new products at suppliers – working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities. The technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers. Provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product. Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements.

Requirements

A minimum of a Bachelor's degree is required.
A degree concentration in Engineering, Life Science , Physical Science and/or related is preferred.
A minimum of 2 years Quality/Manufacturing experience or related experience is required.
Experience in the medical device, pharmaceutical or other highly regulated industry is preferred.
Knowledge of ISO and/or cGMP regulations is preferred.
Experience in a FDA regulated environment is preferred.
An ASQ certification (CQE, CQM, CRE or CQA) is preferred.
Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is preferred.
Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
It is required to be able to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Operations, Medical Affairs, Compliance, Manufacturing, etc.
Auditing experience is preferred.
Strong root cause analysis skills are required.
Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and effects analyses is strongly preferred.
This position may require up to 10% domestic travel.

Responsibilities

Issues resolution with suppliers – investigating challenging issues with significant business impact.
Developing and maintaining suppliers – executing Supplier Reviews, audit related activities and deep dive Technical Assessments at suppliers.
Development/negotiation of Quality Agreements with suppliers.
Changing the way we do business – continuously improving our policies and procedures.
Supplier process changes – assessing, documenting, validating, and leading or approving significant changes in supplier processes (including component approval activities).
Stabilizing new products at suppliers – working with NPD and suppliers to ensure a smooth product launch from a supplier perspective, through both pre- and post-launch activities.
The technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
Provide leadership in design & implementation of world-class quality engineering to support the entire product life cycle with focus on quality engineering activities such as root cause analysis, corrective/preventive action, risk management, analytics/statistical techniques, verification & validation, and design control across the lifecycle of the product.
Provide leadership and technical expertise to ensure supplier conformance to applicable ISO, FDA (Food & Drug Administration) & MDD (Medical Devices Directive) requirements.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits