Johnson & Johnson, Staff Supplier Quality Engineer - Application via WayUp

WayUp; San Jose (CA); On-site; USD 114,000 - 198,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Staff Supplier Quality Engineer in San Jose, CA. This role involves providing quality assurance leadership in managing supplier qualifications, driving continuous improvement initiatives, and ensuring compliance with regulatory standards. The ideal candidate will have a strong background in quality systems and experience in a regulated industry, contributing to the development of smarter, less invasive treatments.

Benefits

Annual performance bonus

Medical, dental, and vision insurance

401(k) retirement plan

Generous vacation and sick leave

Qualifications

• Minimum of 6 years of experience in a regulated industry.
• Understanding of Medical Device Quality Systems.
• Knowledge of FDA and ISO regulations preferred.

Responsibilities

• Lead defect resolution and continuous improvement activities.
• Perform quality processes including change control and supplier nonconformance.
• Support supplier/EM quality evaluations and provide inspection support.

Skills

Quality Assurance

Root Cause Analysis

Continuous Improvement

Risk Management

Data Analysis

Education

Bachelor’s Degree in Engineering or related science/technical field

Advanced Degree

Tools

Word

Power Point

Excel

Job description

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

Job Function:

Quality

Job Sub Function:

Supplier Quality

Job Category:

Professional

All Job Posting Locations:

San Jose, California, United States of America

Job Description:

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

We are searching for the best talent for Staff Supplier Quality Engineer to be located at San Jose, CA.

The Staff Supplier Quality Engineer provides overall quality assurance leadership in the management and qualification of supplier and/or external manufacturers (EMs) for pre- and on-market product for RAD Monarch. Establishes and maintains quality assurance programs, procedures, and controls, ensuring that performance metrics of both the supplier quality systems and suppliers are continually measured to drive improvement initiatives. This position aids in the identification and elimination of supply chain risks via internal and supplier partnerships. Leads/participates in supplier/EM engagements to assess technical competency and general compliance to requirements, i.e., material specifications, CTQs, process control plans, and quality agreements. Key areas of focus within supplier management are leading supplier & process qualifications, leading issue/defect resolution, managing performance monitoring/reporting, compliance to J&J standards, and streamlining processes. Key areas of support provided to team members include risk management/communication, defect resolution, process capability/process improvement, and quality assurance general support. Adheres to environment policy, procedures, and supports department environmental objectives.

You will be responsible for :

• Performs quality processes including change control, supplier nonconformance, quality agreements. Participate in local site supplier/EM quality meetings to ensure communication and alignment of quality initiatives/objectives. Lead supplier/EM quality evaluations. Provide third party inspection support.
• Lead defect resolution, root cause investigation, and continuous improvement activities. Collaborate across functions to confirm if nonconformances are supplier/EM related as applicable.
• Support internal and/or external cross-functional and cross-sector project teams driving supplier/EM improvement and general initiatives through reducing variations in supply chain, institute control plans, and improving process capability. Provide Quality Engineering support to suppliers/Ems including verification/validation activities. Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Tree Analysis (FTA), Root Cause Analysis, Design of Experiments (DOE) et., to the development of new products or processes related to raw materials, services, and finished products.
• Accountable, as applicable for compliance in accordance with regulations.
• Maintain, support compliance of, and improve supplier/EM quality processes, including procedural and electronic systems. Support alignment with enterprise standards and executing gap assessment. Provide regulatory guidance and interpretation to internal and external partners with regards to the following areas: EM and Supplier Quality procedures and medical devices.
• Participate in decisions that are aligned with management objectives regarding work processes, plans, and schedules to achieve department objectives.
• Tracks and report progress across projects and department commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans.

Qualifications

Education:

• Bachelor’s Degree in Engineering or related science/technical field or equivalent is required. Advanced Degree is preferred.

Experience/Skills:

• Minimum of 6 years of experience as a professional in a regulated industry (Biotech, Pharma or Medical Device manufacturing) is required.
• Demonstrates an understanding of the Medical Device Quality Systems, emphasis on purchasing controls is required.
• Demonstrated knowledge of manufacturing principles and practices, and ability to deal with complex issues using deductive reasoning, critical analysis skills and systematic approaches is required.
• Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls is preferred.
• Working knowledge of Word, Power Point and Excel with competency in moderately complex functions for data analysis and trending is required.
• FDA and ISO regulations knowledge in GMP, 21 CFR 820, ISO 13485, ISO 9001, Canadian CMDCAS, Japanese PAL, Brazilian ANVISA, and/or Australian TGA is preferred.
• This position may require up to 30% of domestic and/or international travel.
• Green Belt or higher rank and/or Certified Lead Auditor (ISO 13485) is preferred.
• New production introduction experience is preferred.

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 and 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, please email the Employee Health Support Center ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is:

$114,000 to $197,800

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits