Job Function: Quality
Job Sub Function: Customer/Commercial Quality
Job Category:Professional
All Job Posting Locations:Cincinnati, Ohio, United States of America
Job Description:We are searching for the best talent for a
Senior Post Market Surveillance Specialist to be based in Cincinnati, OH.
About MedTechFueled 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
Purpose: The Senior Post Market Surveillance Specialist is responsible for performing domestic and international product surveillance activities for all medical devices manufactured, marketed, distributed, and serviced by Auris Health, Inc. Primary responsibilities include activities associated with the complaint handling program and regulatory reports. This position reports to the Senior Manager, Post Market Surveillance.
You will be responsible for:- Manage daily workflows for all assigned complaint records.
- Communicate with Service and Sales teams, or other internal personnel, to identify details related to complaint information and event specifics.
- Determine reportability of complaints and submit applicable regulatory reports to the FDA and other Regulatory Agencies, as applicable.
- Perform Good Faith Effort for product return and obtain required information for complaint assessment and evaluation.
- Review investigation records to ensure analysis documentation is appropriate and complete.
- Review complaint records to ensure all the applicable records are created and completed.
- Ensures customer complaint response letters are completed and communicated in a timely and comprehensive manner.
- Understand team performance metrics and strive to achieve targets and goals.
- Perform ad hoc reporting and researching of post market data.
- Support complaint investigations.
- Support lab operations and equipment management.
- Support and participate in internal and external audits.
- Other related duties may be assigned.
Qualifications/Requirements:- Preferred: B.A./B.S. in in a Life Science, Engineering, or similar degree, or equivalent combination of education and experience.
- 3+ years of experience in a commercial medical device company, preferably within Quality. 2+ years in complaint handling.
- Must be highly organized with the ability to manage multiple activities simultaneously and effectively prioritize projects and tasks.
- Familiarity with the applicable US FDA Regulations (21 CFR Part 803, 806, 820), EU Medical Device Regulations, and ISO 13485 standards.
- Excellent written and verbal communication skills.
- An approachable individual who provides a high level of teamwork and cross-functional collaboration.
- Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820.
- This position is based in Cincinnati, OH and is eligible for our J&J Flex hybrid work program (minimum of 3 days on site per week).
- Relocation assistance is not available for this position.
Required Skills:Preferred Skills:Audit Management, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact-Based Decision Making, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
The anticipated base pay range for this position is :$94,000.00 - $151,800.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
