Sr Quality Systems Engineer

Johnson & Johnson Innovative Medicine•Irvine, CA

1d•$94,000 - $151,800

About The Position

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 As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. JOB SUMMARY Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. The Senior Engineer provides high performance quality systems guidance and support for development, maintenance and enforcement of compliance with the company-wide quality management system. This position will have responsibilities in planning, implementing, execution, standardizing, coordinating, and managing QSMR Activities, CAPA, NC, product related Escalations, and Field Corrective Actions (FCA). The QS Engineer will collaborate closely with business partners to provide leadership with regard to Quality System standardization and execution activities to ensure activities are compliant with MD&D Sector, J&J Enterprise Standards and Quality Systems related training. Note: This job description covers both Staff and Senior Engineer

Requirements

Minimum BS/BA required. A preferable degree in engineering, or business discipline and/or an advanced degree is preferred.
Minimum of 4 years of related work experience within FDA regulated industry is required.
Previous Experience in Quality Engineering, Quality Systems, or Quality Assurance work experience is preferred.
Working knowledge of 21 CFR Part 820 and ISO 13485 is required.
Broad-based technical knowledge and experience to work effectively with others in diverse areas of business (Operations, R&D, RA, Field Service, Finance, Marketing/Sales) is required
Ability to effectively prioritize and lead multiple activities is required
Required 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

Nice To Haves

Working knowledge of 21 CFR Part 806 , ISO 14971 and EUMR requirements is preferred.
American Society for Quality (ASQ) CQE, CQA, CMQ/OE, or equivalent professional credential is preferred
Working knowledge of applicable requirements related to the MDSAP jurisdictions is preferred.

Responsibilities

Serve as Quality Systems subject matter expert.
Oversees Quality System metrics and coordinates efforts to maintain a healthy quality system performance.
Track and report action plan status/completion as it relates to quality system improvement efforts.
As needed, assist with creation and modification of Quality System procedures, work instructions and related documentation.
While responsible for CAPA and NC systems, the QS Engineer monitors, and reports Quality Management System metrics to include supporting the Quality System Management Review and QPR.
Can be assigned as Franchise site lead for CAPA and Non-conformance.
Coordinate product issue assessments and Field Action execution.
Lead Quality System Management Review process for either Site or Franchise level
Works on complex investigations and coordinates technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification and validation of CAPA, and subsequent closure of investigations.
While responsible for the execution of the Product Escalation and Field Action, the QM Engineer is responsible for all Field Actions activities as Recall Coordinator – coordinate recall strategy plan definition with business stakeholders, coordinate periodic recall meetings with the Field Corrective Action (FCA) team, maintain meeting minutes, report status to internal departments and regulatory agencies, gather documentation of allactivities and follow up recall activities to successful completion per established recall strategy.
Responsible for managing and executing the issues escalations process to ensure critical/ significant quality issues impacting the product in the field are presented to the Quality Review Board for decision in containment/ corrections to be implemented for these in the field.
Sees opportunities to continuously improve quality systems and processes in alignment with overall quality and business objectives
Supports and participates in cross-functional projects when assigned/appropriate
Facilitates technical innovations to enhance Quality systems and support business goals
Support Audit Readiness and Execution for internal and external audits (e.g. Registrar, Notified Body, FDA, or customer audits)
Facilitates training program
Assesses and implements internal standards, external standards, and regulations, and tracks and influences others on the assessment of internal standards, external standards, and regulations
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures
Performs other duties assigned as needed

Benefits

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.
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
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