Senior Quality Engineer
About The Position
Johnson & Johnson is currently recruiting for a Senior Quality Engineer! This position will be located in Santa Clara, CA. The Senior Operations Quality Engineer will be responsible for providing quality engineering oversight for the manufacture of capital systems. The ideal candidate has experience supporting complex electro-mechanical, software-controlled systems for medical applications. This individual will work with engineering and manufacturing operations teams within the company. This position requires knowledge of medical device regulatory requirements and standards such as ISO 13485, ISO 14971, and 21 CFR 820. Candidate should also have knowledge of and experience with equipment qualifications and process validations (IQ, OQ, PQ), and test method validations.
Requirements
- A minimum of a Bachelor’s degree in Engineering is required.
- Focus degree in mechanical engineering, electrical engineering, or biomedical engineering is preferred.
- A minimum of 4 years of experience in a Quality, Manufacturing, or Engineering function supporting production equipment/systems
- Previous experience in Medical Devices industry working in compliance to ISO 13485 and 21 CFR 820
- Experience with Risk Management documentation (such as pFMEAs) and ISO 14971
- Experience with equipment qualifications and process validations (IQ/OQ/PQ), and Test Method Validations (TMVs)
- Experience with leading failure investigations and managing non-conformances and/or CAPAs
- Experience with statistical analysis and process capability assessments
- Advanced technical, analytical, and problem-solving skills
- Strong written and verbal communication communication skills, and the ability to work effectively as a team member
- Attention to detail and commitment to compliance and data integrity
- Collaborative, able to work cross‑functionally and influence without direct authority
Nice To Haves
- Experience supporting complex electro-mechanical, software-controlled systems for medical applications
- Six Sigma Green Belt Certification
Responsibilities
- Identifies and leads Quality Engineering projects including defining strategies, project plans, key milestones, and objectives in collaboration with cross-functional partners for respective product line
- Responsible for reviewing documentation to ensure outputs adhere to established quality, safety, and regulatory compliance requirements
- Provides quality oversight for equipment qualifications, process validations, and test method validations (IQ/OQ/PQ/TMV) for current and new processes
- Provides quality oversight for the development of/revisions to manufacturing and test process instructions
- Responsible for documenting and reviewing risk assessments, risk analysis, and FMEA's
- Leads production Material Review Board (MRB) meetings and manage non-conformance tracker for applicable product line
- Lead cross‑functional teams to identify, investigate, and resolve production issues arising from non‑conformances, CAPAs, or audit findings
- Supports 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
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
