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Johnson & Johnson · 3 days ago
Senior Quality Engineer
Santa Clara, CA
Full-time
Onsite
Senior Level
$105K/yr - $167K/yr
4+ years exp
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Responsibilities
Identifies and leads Quality Engineering projects including project plans, key milestones, and objectives, to ensure deliverables are aligned with customer's operational needs and requirements for respective sub-system/product line
Identifies and leads Quality Engineering non-conformances, risk assessments, investigation, root cause analysis, and implementation of corrective/preventative actions
Responsible for reviewing documentation to ensure outputs adhere to established quality, safety, and regulatory compliance requirements
Responsible for reviewing documentation of Verification/Validation/Qualification (TMVs, Process Validations, IQ/OQ/PQ) for current and new processes
Defines quality strategies for product quality plans/protocols/engineering studies in collaboration with other quality or product development team members for respective sub-system/product line
Responsible for creating, updating, and/or reviewing risk assessments, risk analysis, and FMEA's
Establishes ongoing training of Quality Assurance Specialists and/or Manufacturing Technicians to Good Documentation Practices and Data Integrity, as well as quality processes/strategies and site-specific policies/procedures
Assesses and addresses Quality Engineering issues or concerns and escalates, as needed, to the next management level
Lead production Material Review Board (MRB) meetings and manage non-conformance tracker for applicable product line(s)
Support corrective/preventive action teams in resolving production, customer and supplier issues (e.g., nonconformances, CAPA or CAPA activities, audit findings, complaint investigations, etc.)
Qualification
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Required
A minimum of a Bachelor's degree in Engineering is required. Focus degree in mechanical engineering, electrical engineering, biomedical engineering is preferred.
A minimum of 4 years of experience in a Quality, Manufacturing, or Engineering function
Previous experience in Medical Devices industry
Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820
Experience creating, updating, and reviewing Risk Management documentation (pFMEAs)
Experience supporting Verification/Validation/Qualification activities and creating, updating, and reviewing related documentation (TMVs, Process Validations, IQ/OQ/PQ)
Experience with leading Failure Investigations and managing non-conformances and/or CAPAs
Advanced technical, analytical, and problem-solving skills
Strong interpersonal, organizational, and verbal and written communication skills and the ability to work effectively as a team member
Preferred
Experience supporting complex electro-mechanical, software-controlled systems for medical applications
A Six Sigma Green Belt Certification
This position requires to work fully onsite in Santa Clara, CA site and may require up to 10% domestic or international travel.
This is a full-time position that may require occasional evening and weekend work based on business needs.
Benefits
Medical Insurance
Dental Insurance
Vision Insurance
Life Insurance
Short- and Long-Term Disability Insurance
Business Accident Insurance
Group Legal Insurance
Retirement Plan (401(k))
Vacation
Sick Time
Holiday Pay
Floating Holidays
Work, Personal and Family Time Off
Company
Johnson & Johnson
Johnson & Johnson develops medical devices, pharmaceuticals, and consumer packaged goods.
10,001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (43)
2022 (55)
2021 (40)
2020 (30)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO· nyse:JNJ
Leadership Team
Alex Gorsky
Chairman & CEO
Dominic J. Caruso
Vice President, Finance and Chief Financial Officer
Recent News
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2024-05-29
2024-05-26
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2024-05-24
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