Quality Assurance Specialist Lead

Johnson & Johnson Innovative Medicine • Santa Clara, CA

1d • $69,000 - $111,090 • Onsite

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.
Johnson & Johnson is currently recruiting for Quality Assurance Specialist Lead! This position will be located in Santa Clara, California.
Position Summary:
The Quality Assurance Specialist Lead is responsible for supporting and maintaining the effectiveness of the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, internal quality standards, and organizational objectives. This role applies quality assurance principles and risk-based decision-making to support product quality, compliance initiatives, continuous improvement activities, and cross-functional collaboration. The incumbent serves as a quality advocate by identifying risks, driving corrective actions, and promoting a culture of compliance and operational excellence. This individual will lead a team of quality special responsible for in-process quality inspections and the quality activities related to final product release of capital systems and accessories for a medical robotic system.

Requirements

• 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.
• Knowledge of applicable quality system regulations and standards, including FDA regulations, ISO standards, Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as appropriate.
• Strong analytical, problem-solving, and risk assessment skills.
• Excellent written and verbal communication skills with the ability to influence and collaborate across functional teams.
• Proficiency in quality management systems, quality metrics reporting, investigations, CAPA, and continuous improvement methodologies.
• Demonstrated ability to manage multiple priorities in a regulated environment while maintaining attention to detail and compliance.

Nice To Haves

• ERP systems, LMS, QMS and Microsoft Office Suit

Responsibilities

• Apply comprehensive knowledge of Quality Assurance principles, quality systems, and regulatory requirements to support the achievement of organizational goals and quality objectives.
• Review, assess, and approve quality-related documentation, including batch records and electronic batch records, and in-process labeling associated with manufacturing, operational, and business processes to ensure compliance with applicable procedures, standards, and regulations.
• Review and assess non-conformance investigations using SAP and EtQ, final product batch information in MES, equipment status in Maximo (CMMS) and complete business related trainings (LMS).
• Assist in the representation of the Quality Assurance department by attending and participating in meetings, projects, investigations and process improvements.
• Assign work to Quality Assurance technicians, understanding shifting priorities on short notice, delivering updates, communication and acting as the primary Quality Assurance technician for the team, reporting directly to the supervisor and/or management.
• 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.
• Assist in the investigation of quality events, deviations, nonconformances, complaints, and corrective and preventive action (CAPA) activities, ensuring appropriate documentation and resolution.
• Monitor compliance with established quality standards and participate in internal and external audits, inspections, and compliance assessments as required.
• Promote a culture of quality, compliance, continuous improvement, and customer focus throughout the organization.
• Demonstrate Johnson & Johnson’s Leadership Imperatives and uphold the Johnson & Johnson Credo in all professional interactions, business decisions, and team collaborations.

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: Senior
• Education Level: Associate degree