Director of Quality Systems - EPM scientific : Job Details

Get AI-powered advice on this job and more exclusive features.

This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$185,000.00/yr - $225,000.00/yr

Direct message the job poster from EPM Scientific

The Director of Quality Systems will play a key role in supporting this subsidary of one of the largest medical device companies in the world. There extensive experience in quality systems will be a needed in helping grow this medical device company. This position requires hands-on expertise in process validation, quality system management, and Endovascular experience!

The ideal candidate is an experienced Manager/Director who thrives in a dynamic environment, can drive projects, lead a team, and provides mentorship to the team.

Key Responsibilities

• Extensive experience in the medical device industry
• Endovascular (EVAR) experience
• Quality Management Systems expertise

Oversee and maintain quality systems, including change control, CAPA, document control, and risk management processes (e.g., FMEA).

Support internal and external audits, including preparation, response, and follow-up actions.

Conduct gap assessments and remediation activities to ensure compliance with notified body and regulatory requirements (ISO 13485, FDA QSR, CE Mark).

Lead quality system initiatives to improve efficiency and effectiveness.

Qualifications

Bachelor's degree in Engineering, Science, or a related technical field.

Preferred:

Experience supporting notified body audits and FDA inspections.

Knowledge of supplier quality management and lean manufacturing principles.

Certifications such as CQE (Certified Quality Engineer) or Six Sigma Green Belt/Black Belt.

Background in catheter manufacturing, process validations, or medical device product development.

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesMedical Equipment Manufacturing

Referrals increase your chances of interviewing at EPM Scientific by 2x

Get notified about new Director Quality System jobs in San Jose, CA.

San Jose, CA $201,960.00-$224,400.00 3 days ago

Union City, CA $213,282.00-$355,908.00 1 week ago

Director, Health Access and Quality (San Bernadino, CA)

San Jose, CA $85,000.00-$95,000.00 3 days ago

San Francisco Bay Area $256,000.00-$320,000.00 2 weeks ago

Sr. Director of Hardware Systems EngineeringExecutive Director Service Lines - FT - Days - Neurosciences, Orthopedics, and Spine

Mountain View, CA $95.92-$143.88 1 week ago

Santa Clara, CA $135,000.00-$185,000.00 2 days ago

Santa Clara, CA $135,000.00-$185,000.00 2 days ago

Milpitas, CA $200,000.00-$230,000.00 10 hours ago

Regional Director of Quality Engineering

San Jose, CA $109,000.00-$125,350.00 4 days ago

Early Childhood Mental Health Clinical Supervisor

Livermore, CA $75,000.00-$90,000.00 2 weeks ago

Staff HR Program Manager, Performance & Promotions

Mountain View, CA $143,500.00-$208,500.00 2 days ago

SBC Clinical Laboratory Scientist I - Night Shift (10 or 11pm start)SBC Clinical Laboratory Scientist I - Technical Services - Evening Shift (2pm Start)SBC Clinical Laboratory Scientist I - Night Shift (10 or 11pm start)SBC Clinical Laboratory Scientist I - Technical Services - Evening Shift (2pm Start)

San Jose, CA $166,000.00-$196,000.00 1 day ago

Construction Quality Assurance Specialist-Program ManagerStaff Failure Analysis and Test EngineerSr. Software Quality Engineer, Redwood City (Onsite role)

Redwood City, CA $125,250.00-$172,220.00 2 weeks ago

San Jose, CA $127,000.00-$149,000.00 2 weeks ago

San Jose, CA $175,000.00-$250,000.00 2 weeks ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr