Quality Assurance Specialist Lead

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 Assurance

Job Category:

Business Enablement/Support

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

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.

Key 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 & Johnsons Leadership Imperatives and uphold the Johnson & Johnson Credo in all professional interactions business decisions and team collaborations.

Qualifications:

Education:

Associates degree in Engineering Life Sciences Quality Management Business or a related discipline preferred.

Skills & Capabilities:

• 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.

Core Competencies:

• Quality Systems Management
• ERP systems LMS QMS and Microsoft Office Suit
• Regulatory Compliance
• Risk Management
• Continuous Improvement
• Documentation Control
• Audit and Inspection Readiness
• Cross-Functional Collaboration
• Investigation and Root Cause Analysis
• Customer Focus
• Leadership and Accountability

This role contributes significantly to maintaining product quality ensuring regulatory compliance and driving continuous improvement initiatives that support organizational success and customer satisfaction.

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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$69000.00 - $111090.00

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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