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Form of workJohnson & Johnson Vision, part of Johnson & Johnson Family of Companies, is recruiting a Sr. Analyst Quality Assurance Lead to be located at Irvine, CA. Remote work options may be considered on a case-by-case basis, and if approved by the company.
At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life-to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
The Sr. Analyst Quality Assurance Lead will be responsible for handling end to end product quality complaint activities and adverse events, including performing Medical Device Reporting (MDR) assessments. Additionally, the Sr. Analyst Lead will provide instruction and feedback to the group as needed and ensure completeness and consistency of complaint and MDR documentation. The position manages and collaborates with business partners and stakeholders (Out Sourced Extended Team, Clinical, Local Operating Companies, Internal/External Manufacturing Sites, Rapid Response Team, Medical Safety and R&D) to deliver effective change management, drive process improvements and identify opportunities to improve the accuracy, efficiency and timeliness of the complaint and MDR processes.
This may include risk assessing the impact of proposed changes to the complaint handling/MDR process within and across functional/regional areas and supporting the global organizational change effectively. The Sr. Analyst QA Lead must have the ability to lead projects and communicate effectively with all levels of management as part of stakeholder engagement and change management roll out.
Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!
Key Responsibilities:
- Assists in the oversight and monitoring of for daily thru put of complaints and MDR decisions to ensure prioritization and critical metrics are met.
- Supports business critical issues in complaint handling and tracks regulatory changes.
- Implements processes to ensure internal organization's alignment with overall quality priorities.
- Designs systems to collect and provide feedback to ensure continuous improvement of the complaint handling management system.
- Assists in review of policies that may impact organizational objectives.
- Support internal and external audits and inspections; ability to communicate regulatory and process positions as an SME during regulatory inspections and provide follow-up support as required.
- Delivers complex research and data related to regulatory changes, external trends, and strategy.
- Serve as a point person for post market and complaint handling regulatory/MDR questions and inquiries; provides mentorship and direction to subordinate Analyst roles and other PMS functions.
- Understands and applies Johnson & Johnson's Credo and Leadership Imperatives in day-to-day interactions with team.
- A minimum of a Bachelor's degree in technical, scientific, or engineering is required. Focus degree in Biomedical Engineer, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred. A Master's degree is preferred.
Required:
- A minimum of 4 years of related experience including Quality Assurance and/or Quality Control, including experience working in pharmaceutical and/or Medical Device or other related highly regulated industry.
- Experience working in an FDA regulated environment.
- Experience in creating/editing work instructions/procedure through controlled documentation process.
- Knowledge and experience in Ophthalmology
- CAPA and Non-conformance experience.
- Possesses strong organization skills supporting the ability to prioritize and manage workload and meet performance expectations.
- Excellent interpersonal, oral, and written communication skills including ability to lead meetings.
- PC knowledge to include Microsoft office is required.
- This position may require up to a 10% travel domestically and/or internationally.
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)).
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
This job posting is anticipated to close on 02/09/2024. 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.
