Senior Supplier Quality Engineer

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

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Cincinnati Ohio United States of America

Job Description:

About Surgery

Fueled by innovation at the intersection of biology and technology were 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 thats 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 worlds 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 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.

Qualifications / Requirements:

• A minimum of a Bachelors degree is required. A degree concentration in Engineering Life Science Physical Science and/or related is preferred. An advanced degree 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.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning Coaching Customer Centricity Data Savvy Document Management Financial Competence Good Automated Manufacturing Practice (GAMP) Lean Supply Chain Management Process Improvements Quality Control (QC) Quality Services Quality Standards Quality Systems Documentation Quality Validation Science Technology Engineering and Math (STEM) Application Supervision Supply Planning Technologically Savvy

The anticipated base pay range for this position is :

$79000.00 - $127650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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: - Experience:

Senior IC