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 .

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.

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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 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 & Johnsons Family of Companies and is recruiting for anEngineer I Source Quality to belocated inWarsaw IN.

About MedTech

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

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.

Responsibilities:

Qualifications

Education:

• A minimum of a Bachelors 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 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.

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