Job Information
J&J Family of Companies Staff Source Quality Engineer in Irvine, California
Staff Source Quality Engineer - 2406196478W
Description
Johnson & Johnson is recruiting for a Staff Source Quality Engineer (SQE), located in Irvine, CA!
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions 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/ .
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Staff Source Quality Engineer (Staff SQE) provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The Staff SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the CSS franchise. They own the deployment of the Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, and initiatives for suppliers of the CSS supply chain.
Key Responsibilities:
Lead, develop, and implement Supplier/Purchasing controls and associated activities including Approved Supplier List management.
Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management.
Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
Analyze supplier performance metrics, identify area of opportunity, communicate supplier risks, and drive resolution of quality issues and risk control processes.
Implement Supplier Change Management process including change notification, impact assessment, and approval.
Prepare Supplier Quality Agreements and drives discussion with supplier.
Qualifications
Education:
- Bachelor's degree or equivalent in Engineering, an Applied Science or a related technical and quality field is required.
Experience and Skills:
Required:
A minimum of six (6) years of relevant work experience is required.
Experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation.
Solid understanding of regulatory compliance requirements (Quality System Regulations (QSRs), Medical Device Regulation (MDR), ISO 9001, ISO 13485, ISO 14971 or other international standards).
Prior manufacturing, plant or technical background and knowledge of manufacturing principles and practices.
Broad experience with quality systems (validation, non-conformance, CAPA and investigations, production and process controls).
Preferred:
Working experience in good manufacturing practice (Medical Device, Pharmaceutical, etc.) and direct experience in plant and/or supplier GMP auditing.
Component Qualification/Process Validation and New Product Introduction experience.
Strong analytical skills, metrics development and ability to identify trends.
Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®).
Other:
This position will be located in Irvine, CA, and may require up to 25% domestic or international travel.
The anticipated base pay range for this position is $90,000 to $144,900.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits:
– Vacation – up to 120 hours per calendar year
– Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
– Holiday pay, including Floating Holidays – up to 13 days per calendar year
– Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
This job posting is anticipated to close on July 10, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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 (https://jnjc.taleo.net/enterprise/www.careers.jnj.com) .
Primary Location NA-US-California-Irvine
Organization Biosense Webster Inc. (6010)
Travel Yes, 25 % of the Time
Job Function Supplier Quality
Req ID: 2406196478W