Engineer 1, Source Quality

6029-MEDICAL DEVICE BUSINESS SERVICES, INC. Legal Entity; United States; On-site; USD 60,000 - 90,000; Full time

Job summary

Johnson & Johnson is seeking an Engineer I, Source Quality (Orthopedics) in Warsaw, IN to drive supplier quality for external manufacturers. This role supports quality leadership, process controls, and successful product launches within a global medical device framework.

You will apply GMP/ISO 13485 knowledge, perform root cause analyses, and collaborate with R&D, Regulatory, Manufacturing, and Marketing to ensure high-quality orthopedic products reach patients safely.

Qualifications

• Bachelor's degree in Engineering required.
• 0-2 years of related experience.
• Excellent problem solving and decision‑making skills.
• Strong communication and interpersonal skills.
• Knowledge of manufacturing processes; machining, injection molding, additive manufacturing and/or electronics manufacturing.
• Six Sigma, Lean, or ASQ certification/training desired.
• Experience with blueprint reading/LT/D, GD&T.
• Familiarity with inspection methods and techniques.
• Knowledge of FDA CFR Part 820 and ISO 13485.
• Willingness to travel up to 25%.

Responsibilities

• Provide quality engineering leadership for select suppliers and materials.
• Establish quality expectations at suppliers and ensure conformance.
• Maintain and improve production and process controls using SPC and related metrics.
• Support product development teams for successful launches at suppliers.
• Conduct supplier audits and uphold GMP and quality standards.
• Lead root cause investigations and verify corrective actions.
• Apply risk management tools and failure mode analysis.
• Coordinate跨departments such as R&D, Regulatory, Manufacturing, and Marketing.

Skills

Problem solving

Communication

Interpersonal skills

Quality engineering

Flexibility

Education

Bachelor's degree in Engineering

Tools

GD&T

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: Supply Chain Engineering Job Sub Function: Quality Engineering Job Category: Scientific/Technology

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. DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies and is recruiting for an Engineer I, Source Quality, Orthopedics to be located in Warsaw, IN. 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 DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

Key Responsibilities

• Under the direction of a Sr. Engineer, the Engineer I, Provides quality engineering leadership in the management of select External Manufacturers, Direct Material, and Indirect material suppliers.
• Responsible for technical leadership in establishing quality expectations at the supplier.
• Implements, and/or maintains, production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, process performance metrics).
• Partner with product development teams to support successful launches at suppliers.
• Conduct supplier visits emphasizing quality improvement and compliance with good manufacturing practices, ISO-13485 and other applicable standards.
• Provide Quality Engineering support to suppliers including inspection technique support, product non-conformances, verification/validation activities.
• Contributes to root cause investigations using various problem-solving techniques and tools, and assesses corrective action effectiveness.
• Applies various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode, effects analysis).
• Communicate at all levels within Quality and across functions or departments such as R&D, Regulatory, Manufacturing, and Marketing.

Qualifications, Education, and Experience

Qualifications Education: A minimum of a Bachelor's or equivalent university degree in Engineering or related Scientific focus is required. Experience and Skills: Required: 0-2 years of related experience Excellent problem solving and decision‑making skills Communication/Interpersonal skills and flexibility to enable resolution of technical situations Preferred: Relevant work, internship, or Co‑Op experience Experience or knowledge with manufacturing processes; machining, injection molding, additive manufacturing and/or electronics manufacturing Medical Device and/or Pharmaceutical industry Six Sigma, Lean, or ASQ Certification/training Quality engineering experience Experience with Blueprint reading/literacy including GD&T Familiarity with inspection methods and techniques Knowledge of FDA CFR Part 820 and ISO 13485 Experience with process validation Other: This position may require up to 25% travel Johnson & Johnson

Equal Opportunity Employment

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.

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 https://www.jnj.com/.