Engineer 3, Source Quality

Johnson & Johnson MedTech; Warsaw (IN); On-site; USD 85,000 - 110,000; Full time

Job summary

Johnson & Johnson MedTech in Warsaw, IN seeks an Engineer 3, Source Quality to lead supplier quality initiatives and audits, collaborating with procurement, engineering, and R&D teams. You will evaluate suppliers, drive corrective actions, and support quality metrics with data-driven decisions.

The role emphasizes governance of supplier quality, risk analysis, and capability improvements to ensure product conformance. 25% travel may be required and relocation support is not provided.

Qualifications

• Bachelor's degree in Engineering or technical field required.
• Minimum 4 years of relevant experience in Medical Device or Pharma industry.

Responsibilities

• Lead supplier quality initiatives and audits to improve supplier performance.
• Coordinate investigations and risk analysis for supplier non-conformances.
• Develop corrective and preventive actions and verify effectiveness.
• Collaborate with procurement, engineering, and quality teams to ensure compliance.

Skills

Analytical Reasoning

Data Savvy

Quality Systems

Lean Six Sigma

Process Improvements

GxP

Coaching

Supervision

Documentation

Engineering

Education

Bachelor's degree in Engineering

Tools

SPC

Gage R&R

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 jnj.com.

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.

Job Function

Job Sub Function

Job Category

All Job Posting Locations

Warsaw, Indiana, United States of America

Job Description

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

We are searching for the best talent for Engineer 3, Source Quality located in Warsaw, IN.

An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

About MedTech

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

Position Summary

This Engineer 3, Source Quality will use talent to be an individual contributor and lead ad hoc teams. They will collaborate with Procurement, Engineering, R&D, Quality, Operations, and suppliers to implement solutions and improve suppliers’ quality, compliance, and overall service/performance. They will also support and lead initiatives to improve suppliers’ performance in order to certify them or reduce receiving inspection activities. Visit and evaluate suppliers through audits or technical assessments. Support the Quality Audit group by providing quality metrics and supplier performance data.

Key Responsibilities

• Support the incoming inspection group (technician, team lead supervisor, etc.) on the decision-making process and follow-up of material non-nonconformance with suppliers.
• Responsible to coordinate supplier investigations, related to material non-conformances. Participate or lead investigation process and risk analysis of supplier quality excursions.
• Works directly with suppliers and external manufacturers to ensure the products and services received meet requirements and/or specifications.
• Approve and/or advance deviations to product specifications or processes.
• Responsible for generating corrective and preventive actions to suppliers, and verification of the efficacy of such actions for approval and closure
• Support supplier implementation of improvement activities (for example Lean, 6s, SPC, Gage R&R, etc.).
• Collaborate and support the introduction of new products in relation to new components or finished devices provided by suppliers.
• Supports the qualification, validation/certification of supplier's inspection methods and equipment.
• Responsible for the generation and updates to Supplier Quality Agreements.
• Participate with other functional groups and support activities related to changes requested by or to suppliers.
• Responsible to create, review, and approve changes to company procedures, work instructions, forms, inspection reports and other related controlled documentation.
• Attend and participate in quality metric reviews. Responsible for presenting business-related issues or opportunities to next management level.
• Capable of developing junior quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data-driven, risk-based decisions that ensure the quality of the product.

Qualifications/Requirements

• A minimum of a Bachelor's or equivalent university degree is required, with a preferred focus in Engineering or Technical field.
• A minimum of 4 years relevant work experience in the Medical Device or Pharma Industry.

Preferred

• Professional certification - ASQ : CQE, Lean, Six Sigma, Etc.

Other

• This position may require up to 25% domestic travel.
• Candidates must already have authorization to work in the country of employment. This role is eligible for immigration sponsorship, if required. Relocation support is not available for this position.

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 https://www.jnj.com/contact-us/careers. 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 Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy