Quality Specialist NPD - Integration
Apply NowCompany: Johnson and Johnson
Location: Irvine, CA 92620
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:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Irvine, 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
Johnson & Johnson is hiring for a Quality Specialist NPD - Integration to join our team located in Irvine, CA.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Specialist NPD - Integration will play a key role in supporting the integration and remediation efforts following an acquisition, ensuring alignment with quality plan deliverables. This position requires collaboration with cross-functional teams to identify and implement process improvements in quality systems, while also assisting with Non-conformances, Corrective and Preventive Actions (CAPA), and audits. The specialist will facilitate training programs, lead document changes within the Product Lifecycle Management System, review quality documentation for compliance, and communicate effectively across various departments to gather critical information. Additionally, the role involves preparing trend reports, maintaining adherence to Quality Management System procedures, and upholding the company's standards and regulations in relation to health, safety, and environmental practices.
Key Responsibilities:
Qualifications
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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$63,000 to $102,350
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
Job Function:
Quality
Job Sub Function:
Quality Assurance
Job Category:
Professional
All Job Posting Locations:
Irvine, 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
Johnson & Johnson is hiring for a Quality Specialist NPD - Integration to join our team located in Irvine, CA.
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Specialist NPD - Integration will play a key role in supporting the integration and remediation efforts following an acquisition, ensuring alignment with quality plan deliverables. This position requires collaboration with cross-functional teams to identify and implement process improvements in quality systems, while also assisting with Non-conformances, Corrective and Preventive Actions (CAPA), and audits. The specialist will facilitate training programs, lead document changes within the Product Lifecycle Management System, review quality documentation for compliance, and communicate effectively across various departments to gather critical information. Additionally, the role involves preparing trend reports, maintaining adherence to Quality Management System procedures, and upholding the company's standards and regulations in relation to health, safety, and environmental practices.
Key Responsibilities:
- Support integration and remediation efforts, ensuring alignment with quality plan deliverables.
- Collaborate with cross-functional teams to identify and address process improvements in quality processes
- Assist in the execution of Quality System activities, including Non-conformances, Corrective and Preventive Actions (CAPA), and audits.
- Facilitate the organization and implementation of training programs across the organization.
- Lead document changes in the applicable Product Lifecycle Management System.
- Review and evaluate quality documentation for compliance and accuracy.
- Communicate effectively with diverse functions (such as Production, Materials, QA, and QE) to obtain necessary information.
- Prepare reports based on collected data for the purpose of identifying trends (f.e. QSMR).
- Perform data entry related to Quality Assurance and generate necessary reports.
- Assist in preparing for audits, as well as conducting and following up on both internal and external audits.
- Collect and update information to ensure adherence to Quality Management System procedures.
- Work collaboratively with other teams to collect information, follow up on outstanding tasks, and more.
- Support the company's goals and objectives, policies and procedures, applicable Quality System Regulations (QSR), and FDA regulations.
Qualifications
- A minimum of a Bachelor's degree is required
- A minimum of 2 years of related experience performing Quality System related activities in the medical device industry.
- Working knowledge of cGMP, FDA 820 QSR and ISO 13485 or other Quality Systems.
- Proficiency in data compilation, analysis, presentation, and document writing skills.
- Excellent written and verbal communication skills.
- Excellent organizational skills.
- Experience with computer-based applications (MS Word, MS Excel).
- Operate as a team and/or independently while demonstrating flexibility to changing requirements.
- This position may require up to a 25% of domestic 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 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 (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$63,000 to $102,350
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