Quality System Specialist

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:

Milpitas California United States of America

Job Description:

Johnson & Johnson is currently recruiting for a Quality System Specialist! This position can be located in Milpitas CA.

Position Summary:

The Quality System Specialist is responsible for supporting the administration maintenance monitoring and continuous improvement of the Quality Management System (QMS) to ensure compliance with FDA Quality System Regulations (21 CFR Part 820/QMSR) ISO 13485 company policies and other applicable regulatory requirements. This role supports document control change control training management CAPA activities quality system remediation projects compliance monitoring quality metrics reporting Quality Management Review (QMR) activities and audit readiness initiatives.

The individual works cross-functionally with Quality Regulatory Affairs Manufacturing Engineering Operations and Supply Chain to ensure that quality system processes are effectively implemented maintained monitored and continuously improved.

Adheres to environmental policy procedures and supports department environmental objectives.

Key Responsibilities:

• Prepare and maintain monthly and quarterly metrics dashboards trend analyses and performance reports to support business objectives and regulatory requirements.
• Coordinate and support Quality Management System Review (QSMR) activities including data collection metric analysis presentation preparation and tracking of action items.
• Facilitate and support Nonconformance (NC) Corrective and Preventive Action (CAPA) and Change Control processes including investigations root cause analysis action tracking and effectiveness verification.
• Support the administration maintenance and monitoring of the Quality Management System (QMS) to ensure compliance with FDA QMSR ISO 13485 company procedures and applicable regulatory requirements.
• Administer document control and records management activities including document review approval release revision retention archival and lifecycle management within electronic systems.
• Assist with internal audits external audits supplier audits and regulatory inspections including audit preparation response coordination remediation activities and closure of findings.
• Analyze quality system data and trends to identify compliance risks systemic issues and opportunities for continuous improvement.
• Support inspection readiness and ongoing compliance monitoring programs to maintain a state of audit readiness.
• Collaborate with cross-functional teams including Quality Regulatory Affairs Engineering Manufacturing Operations R&D Supply Chain Service and IT to ensure effective implementation and continuous improvement of QMS processes.
• Participate in quality system enhancement process harmonization digital transformation and operational excellence initiatives.
• Perform additional duties and special projects as assigned in support of Quality Systems Compliance and Quality Assurance operations.

Qualifications:

Education:

A minimum of a bachelors or equivalent University degree is required with a focus in scientific engineering business or related discipline preferred. Equivalent combination of education and relevant experience may be considered.

Skills & Capabilities:

• 2-5 years of experience in Quality Assurance Regulatory Compliance or related functions within a regulated industry.
• Medical Device industry experience preferred.
• Experience working in FDA-regulated and/or ISO 13485 environments preferred.
• Experience with electronic Quality Management Systems (eQMS) Agile PLM SAP ETQ ComplianceWire or similar systems preferred.
• Experience supporting NC/ CAPA Change Control Audit Management and Document Control processes preferred.
• Working knowledge of FDA 21 CFR Part 820/QMSR ISO 13485 MDSAP and related quality system requirements.
• Understanding of CAPA Change Control Document Control Training Risk Management and Audit processes.
• Strong project management organization and prioritization skills.
• Ability to manage multiple projects and deadlines in a fast-paced environment.
• Strong analytical and problem-solving capabilities.
• Strong written verbal and presentation skills.
• Proficiency in Microsoft Office applications (Word Excel PowerPoint).
• Ability to work independently and effectively within cross-functional teams.
• Strong attention to detail and commitment to compliance.
• Excellent interpersonal skills with the ability to influence and collaborate across all organizational levels.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via . internal employees contact AskGS to be directed to your accommodation resource.

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Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$75000.00 - $120750.00

Additional Description for Pay Transparency:

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)).

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: - Experience:

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