Quality System Specialist

Johnson & Johnson Innovative Medicine • Milpitas, CA

2d • $75,000 - $120,750 • Onsite

About The Position

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.

Requirements

• 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.
• 2-5 years of experience in Quality Assurance, Regulatory Compliance, or related functions within a regulated industry.
• 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.

Nice To Haves

• 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.

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level