Sr Quality Systems Engineer

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 Function:

Quality

Job Sub Function:

Quality Systems

Job Category:

Professional

All Job Posting Locations:

Irvine California United States of America

Job Description:

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 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

DUTIES & RESPONSIBILITIES

• In accordance with all applicable federal state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines this position:

• 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

EXPERIENCE AND EDUCATION

• 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.

• SECTION 4: REQUIRED KNOWLEDGE SKILLS ABILITIES CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Working knowledge of 21 CFR Part 820 and ISO 13485 is required.

• Working knowledge of 21 CFR Part 806 ISO 14971 and EUMR requirements is preferred.

• 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

• 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.

Required Skills:

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 :

$94000.00 - $151800.00

Additional Description for Pay Transparency:

This position is eligible to participate in the Companys long-term incentive program.

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



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Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).



This position is eligible to participate in the Companys 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



Additional information can be found through the link below.

Co-Ops and Intern Positions: Please use the following language:

Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.

Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year.

Co-Ops and Interns are eligible to participate in the Companys consolidated retirement plan (pension).



Positions Represented by CBA: Please use the following language:

This position is eligible for benefits to include medical dental vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.



The following link to general company benefits information MUST also be included in the posting: Please use the following language:

For additional general information on Company benefits please go to: - 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