Johnson & Johnson

Quality Assurance Specialist Lead

Santa Clara, California, United States of America

Sponsorship not specified$69k-$111kDetected 12 hours ago

ComplianceSAPProcess ImprovementERPGMPFDA RegulatoryLeadershipCommunicationCollaborationProblem SolvingMicrosoft Office

About the role

The incumbent serves as a quality advocate by identifying risks, driving corrective actions, and promoting a culture of compliance and operational excellence.

Apply comprehensive knowledge of Quality Assurance principles, quality systems, and regulatory requirements to support the achievement of organizational goals and quality objectives.
Maintain and support routine collection, analysis, and reporting of quality metrics and key performance indicators (KPIs) to monitor system effectiveness and identify opportunities for continuous improvement.
Participate in and lead risk mitigation initiatives, process improvement activities, and quality enhancement projects to improve operational efficiency, product quality, and regulatory compliance.
Collaborate with cross-functional stakeholders to identify, assess, and mitigate quality and compliance risks while ensuring timely and effective customer support.
Develop, revise, and maintain quality policies, procedures, work instructions, and related documentation in response to changing regulatory requirements, internal investigations, audit findings, and organizational needs.
Support formal quality escalation processes by identifying, documenting, communicating, and tracking risks related to product quality, quality systems performance, and regulatory compliance.

Knowledge of applicable quality system regulations and standards, including FDA regulations, ISO standards, Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as appropriate.
Monitor compliance with established quality standards and participate in internal and external audits, inspections, and compliance assessments as required.
Education:
Skills & Capabilities:
Excellent written and verbal communication skills with the ability to influence and collaborate across functional teams.
Demonstrated ability to manage multiple priorities in a regulated environment while maintaining attention to detail and compliance.
Core Competencies:
Quality Systems Management
ERP systems, LMS, QMS and Microsoft Office Suit
Regulatory Compliance
Risk Management

Associate's degree in Engineering, Life Sciences, Quality Management, Business, or a related discipline preferred.

Experience in Quality Assurance, Quality Systems, Regulatory Compliance, Manufacturing Quality, or a related field.
Strong analytical, problem-solving, and risk assessment skills.
Proficiency in quality management systems, quality metrics reporting, investigations, CAPA, and continuous improvement methodologies.
The anticipated base pay range for this position is:
$69,000.00 - $111,090.00
Additional Description for

https://www.careers.jnj.com/employee-benefits
Vacation -120 hours per calendar year
Holiday pay, including Floating Holidays -13 days 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
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.

This listing is sourced directly from Johnson & Johnson's careers page and normalized into a canonical job model.