Quality Engineer I

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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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 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 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 & Johnson announced plans to separate our Orthopaedics business toestablish a standalone orthopaedics company operating asDePuySynthes. 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 ofDePuySynthes and your employment would be governed by DePuySynthes employment processes programs policies and benefit that case details of any planned changes would be provided to you byDePuySynthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson MedTech Orthopedics (a member of Johnson & Johnson Family of Companies) is currently seeking a Quality Engineer II to join our outstanding team located in Warsaw Indiana!

The Quality Engineer I position will apply basic Quality Engineering/Scientific Method techniques and principles to daily tasks and activities under general supervision. Individual applies relevant regulations standards and industry guidelines to assignments. Individuals work with experienced Quality Engineers to ensure efficient and effective quality & compliance and continuous improvement in our end-to-end business with a focus on manufacturing operations. This role supports new product introduction continuous improvement initiatives and base business products and processes (risk management nonconformances inspection methods etc.)

Key Responsibilities:

• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820 ISO 13485 GxP and other applicable regulatory requirements

• Support resolution of Quality Issues. Owns and supports investigation bounding actions reviews and approval of non-conformances CAPAs and audit findings.

• Support quality system metrics risk analysis process controls and process improvements.

• Support execution of validation activities and inspection methods.

• Handle conflict resolution as it relates to technical situations.

Qualifications

Education:

• Bachelors Degree in Engineering or equivalent technical/scientific field.

Experience and Skills:

Required:

• 0 2 years experience in a GMP and/or ISO regulated industry and experience with FDA regulated environment.

• Introductory knowledge of Quality Engineering/Scientific methods and techniques.

Preferred:

• Introductory understanding of manufacturing and inspection equipment and processes.

• Knowledge of statistical techniques and/or software packages and the ability to support analysis.

• Experience with project management and demonstrating organizational skills.

• Critical thinking and attention to detail.

• Strong verbal communication and technical writing.

• Capacity to perform hands on problem solving.

Other:

• Ability to proficiently communicate both verbal and written in English.

• This position will be located in Warsaw IN and may require up to 10% domestic or international 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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