QE 4 - Quality Regulatory Requirements
Johnson & Johnson MedTech, Jacksonville, FL, United States
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 jnj.com
Job Function Quality
Job Sub Function Quality Systems
Job Category Professional
All Job Posting Locations Jacksonville, Florida, United States of America
Job Description Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and manages JJVC's process to assess new/revised J&J quality standards.
Collaborates with various functional areas, partners with subject matter experts (SMEs) and regional regulatory affairs, to ensure assessments are initiated, actions are identified and completed, where needed, to ensure alignment with new/revised external standards, global regulatory requirements, and internal J&J quality standards applicable to JJVC's quality management system and JJVC's products.
Monitors external requirements through various sources of information to ensure new/revised regulatory requirements applicable to JJVC are identified and evaluated.
Provides support to quality system, quality system initiatives and audits of quality system.
Provides support for the investigation and actions to address audit findings, nonconformances and corrective actions to further improve the quality system.
Supports and/or participates in various cross-functional teams to align quality system with requirements (internal/external) and/or initiatives for quality system improvement, as directed.
Duties & Responsibilities
Managing JJVC's External Regulatory Requirements Management Process and JJVC process to align with J&J corporate quality standards including initiating assessments, support/follow-up with assessors, review/closure of completed assessments, maintaining procedures, forms, templates, and records associated with these processes.
Monitors various sources of data to identify and initiate evaluations of new/revised external requirements.
Serves as process SME during internal and external audits.
Supports departments objectives in order to meet the organizational goals, quality system improvement initiatives as directed by area manager and performs other related duties as assigned by management.
Supports quality systems audits (internal and external) including follow-up support on investigations and actions taken to address audit findings.
Supports investigations/actions associated with non-conformances and CAPA, as directed by area manager.
Required Skills
Quality Systems – Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part 820 and ISO13485 requirements.
Knowledge of where/how external standards (ISO, etc) and external regulatory requirements are applicable to quality management system and/or product design/development and product regulatory submissions.
Use of applications/systems which support our quality system such as document management system, change control, nonconformance, CAPA, audit, metrics reporting systems, etc.
Ability to work independently and/or collaboratively in order to complete work assignments and tasks.
Manage time, assignments, projects and tasks in a methodical manner to ensure scheduled and planned deliverables are completed on‑time and accurately.
Flexibility to support and manage multiple assignments and associated tasks.
Supportive of innovation, customer‑focused improvements, and participating in such efforts.
Preferred Skills
Agility Jumps
Analytical Reasoning
Analytics Dashboards
Coaching
Collaborating
Communication
Compliance Management
Data Compilation
Data Quality
Data Savvy
Document Management
Problem Solving
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
System Audits
Systems Analysis
The anticipated base pay range for this position is : $94,000.00 - $151,800.00
Additional Description For Pay Transparency Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role.
[DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION]
Please Use The Following Language 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)).
This position is eligible to participate in the Company’s long‑term incentive program.
Benefits 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
#J-18808-Ljbffr
Job Function Quality
Job Sub Function Quality Systems
Job Category Professional
All Job Posting Locations Jacksonville, Florida, United States of America
Job Description Manages Johnson & Johnson Vision Care's (JJVC) External Regulatory Requirements Management process and manages JJVC's process to assess new/revised J&J quality standards.
Collaborates with various functional areas, partners with subject matter experts (SMEs) and regional regulatory affairs, to ensure assessments are initiated, actions are identified and completed, where needed, to ensure alignment with new/revised external standards, global regulatory requirements, and internal J&J quality standards applicable to JJVC's quality management system and JJVC's products.
Monitors external requirements through various sources of information to ensure new/revised regulatory requirements applicable to JJVC are identified and evaluated.
Provides support to quality system, quality system initiatives and audits of quality system.
Provides support for the investigation and actions to address audit findings, nonconformances and corrective actions to further improve the quality system.
Supports and/or participates in various cross-functional teams to align quality system with requirements (internal/external) and/or initiatives for quality system improvement, as directed.
Duties & Responsibilities
Managing JJVC's External Regulatory Requirements Management Process and JJVC process to align with J&J corporate quality standards including initiating assessments, support/follow-up with assessors, review/closure of completed assessments, maintaining procedures, forms, templates, and records associated with these processes.
Monitors various sources of data to identify and initiate evaluations of new/revised external requirements.
Serves as process SME during internal and external audits.
Supports departments objectives in order to meet the organizational goals, quality system improvement initiatives as directed by area manager and performs other related duties as assigned by management.
Supports quality systems audits (internal and external) including follow-up support on investigations and actions taken to address audit findings.
Supports investigations/actions associated with non-conformances and CAPA, as directed by area manager.
Required Skills
Quality Systems – Knowledge of quality system requirements including familiarity with US FDA 21 CFR Part 820 and ISO13485 requirements.
Knowledge of where/how external standards (ISO, etc) and external regulatory requirements are applicable to quality management system and/or product design/development and product regulatory submissions.
Use of applications/systems which support our quality system such as document management system, change control, nonconformance, CAPA, audit, metrics reporting systems, etc.
Ability to work independently and/or collaboratively in order to complete work assignments and tasks.
Manage time, assignments, projects and tasks in a methodical manner to ensure scheduled and planned deliverables are completed on‑time and accurately.
Flexibility to support and manage multiple assignments and associated tasks.
Supportive of innovation, customer‑focused improvements, and participating in such efforts.
Preferred Skills
Agility Jumps
Analytical Reasoning
Analytics Dashboards
Coaching
Collaborating
Communication
Compliance Management
Data Compilation
Data Quality
Data Savvy
Document Management
Problem Solving
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Services
Quality Standards
System Audits
Systems Analysis
The anticipated base pay range for this position is : $94,000.00 - $151,800.00
Additional Description For Pay Transparency Please provide the benefits applicable. Required for US Positions. Please copy and paste the applicable benefits into the empty text box below, based on the type of role.
[DELETE ANY BENEFITS NOT APPLICABLE TO THE POSITION]
Please Use The Following Language 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)).
This position is eligible to participate in the Company’s long‑term incentive program.
Benefits 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
#J-18808-Ljbffr