Staff Quality Engineer, Quality Operations - Johnson and Johnson

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Staff Quality Engineer , Quality Operations to be located in San Jose, CA.

Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including robotics, digital solutions, sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com

You will work with cross functional Engineering and Supply Chain teams to support Manufacturing operations for Robotic Medical Devices. Additionally, you will drive improvement and strategic quality processes/procedures, ensure adherence to the J&J QMS and external standards and support New Product Introduction initiatives. This is a great opportunity to work on the forefront of Medical Device Robotics.

Key Responsibilities:

Under limited guidance this position:

• Reviews and analyzes standard operating procedures, specifications, and provides technical transfer and validation support.

• Investigates, reviews and approves non-conformances and corrective/preventive actions

• Interprets and provides feedback on manufacturing, quality, engineering, and validation documents for conformance to standard practices and internal procedures.

• Analyzes data and documentation in support of the development of validation strategies.

• Reviews sampling plans and approves inspection methods for evaluation and testing of components and/or products.

• Oversees planning and integration aspects of new product launches into sustaining processes. Education:

• University/Bachelor's degree or equivalent in Engineering or closely related field of study

Experience and Skills

Required:

• Eight to ten (8-10) years of related work experience

• Experience supporting product development and/or production lines within a regulated industry such as Medical Devices, MedTech, or Pharmaceuticals

• Proficiency with pFMEAs, Test Method Validations, Root Cause, CAPAs, Non-Conformance Management, and Process Validations

• Proficiency with advanced data analysis tools and statistical methods (i.e., ANOVA, DOE, etc.)

• Demonstrated analytical and problem-solving skills, ability to lead and influence others, highly organized

• Outstanding organizational, communication, presentation, and interpersonal skills

• Experience implementing processes/improvements that increase reliability, improve yield, and lower costs

• Proficient with standard business software (MS Office, Excel, Outlook, etc.)

Preferred:

• Experience working with External Manufacturers (EM) to validate and improve manufacturing processes

• Six Sigma Green or Black Belt Certification. ASQ CQE

• Medical Device single use and capital equipment industry experience

• Solid understanding and application of 21 CFR 820, cGMP, ISO 13485, ISO 14971

• Certified ISO 9001/13485 Lead Auditor

• Commissioning/Decommissioning and product/manufacturing transfers.

• Experience with computerized management systems, such as EtQ, SAP, Maximo/CERDAAC

Other:

• English Proficiency

• Travel Up to 20%

• Role is onsite 5 days/week; Will be required to work at Redwood City and Santa Clara sites on occasion

• The anticipated base pay range for this position is $113,000 to $195,730

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .