Senior Engineer, Quality Engineering

Johnson & Johnson

Sr Engineer providing quality leadership in medical device projects at Johnson & Johnson. Collaborating with teams to ensure compliance and risk management in product development.

Posted 6/26/2026full-timeMilpitas • California • 🇺🇸 United StatesSenior💰 $109,000 - $174,800 per yearWebsite

About the role

Key responsibilities & impact

Quality leadership on product project teams and ensures the Critical to Quality (CTQs) attributes cascading requirements (for user needs to product, process, raw materials and test methods) are established, implemented and met.
Ensures effective risk management or product harms and hazards and improves capability of processes.
Leads development team in design control strategy and implementation.
Collaborates with functional business partners to proactively address quality issues during new product development, design changes and product verification/validation.
Leads activities associated with risk management and human factors. This includes working with engineers and product development to identify areas of high risk within their processes; establishing, monitoring and implementing risk mitigation plans; and ensuring management awareness of risks, gaining support for mitigation efforts and tracking progress.
Quality Management Systems support including Design Control, Risk Management, Change Control, Non-Conformance and Corrective Actions and Audits.

Requirements

What you’ll need

Bachelors or equivalent university degree in Engineering or other related technical field is required.
4 years working experience in Design/Process Engineering/Science/Statistics in a regulated industry.
Strong communication, interpersonal and organizational skills.
Practical understanding of QSR/ISO medical device regulations especially design controls, and risk management.
Ability to function in a team environment and deliver on team objectives.
Strong attention to detail.
Strong written and verbal communication skills.
Developed presentation skills.
Preferred: Experience in Medical Device industry.
Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
Human Factors Engineering experience.

Benefits

Comp & perks

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Design ControlRisk ManagementChange ControlNon-ConformanceCorrective ActionsAuditsHuman Factors EngineeringQuality Management SystemsGood Documentation PracticeCorrective and Preventive Action

Soft Skills

CommunicationInterpersonal SkillsOrganizational SkillsAttention to DetailTeam CollaborationPresentation Skills