Lumenous is Hiring!
Lumenous Device Technologies is at the forefront of medical device manufacturing for ultraprecision medical components for interventional catheters, implants, robotic surgery, and a wide variety of components used in minimally invasive medical devices throughout the body. Are you interested in having a fulfilling, successful career supporting quality in a company where every part matters and makes a difference in the world? You can at Lumenous.

Responsibilities

• Provide Quality & Regulatory management for the contract manufacturing location in Santa Clara, CA.
• Serves as the Management Representative.
• Coordinate and maintain regulatory registrations, including notified body certification, registration of products with the US (FDA) and Europe (EUDAMED), and licensing required by the state of California.
• Identify resources required to effectively execute the quality function, and manage assigned resources.
• Lead Quality Plan and CAPA efforts to significantly improve the Quality Management System in response to external regulatory agency and notified body findings.
• Directly responsible for the effective execution of the following Quality Management System processes:
• Document management
• Record control
• Training
• Management Review
• Internal Audits
• Corrective and Preventative Maintenance
• Supplier Controls
• Statistical Techniques
• Risk Management
• Support and enforce the Design, Development and Manufacturing related Quality Management System processes, including the following:
• Product Realization
• Process Validation, including equipment management and quality system related software validation
• Identification and Traceability
• Nonconforming Materials
• Handling, Storage and Distribution
• Test Method Validation
• Facility Controls

Experience/Qualifications

• 5-10 years management or supervisory experience in a Quality or Regulatory role.
• Direct experience in the Medical Device industry.
• Demonstrated knowledge of ISO 13485, 21 CFR Part 820 and Part 11, and the European Medical Device Regulation (EU MDR).
• Experience with current good manufacturing practices (cGMP).
• Experience with contract manufacturing preferred.
• Direct experience with inspections and audits by regulatory agencies.
• Strong interpersonal and communication skills.
• Good technical writing skills.
• Strong attention to detail.

Job Type: Full-time

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Paid time off
• Parental leave
• Retirement plan
• Tuition reimbursement

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday
• Night shift
• Weekends as needed

People with a criminal record are encouraged to apply

Education:

• Bachelor's (Preferred)

Experience:

• Management: 5 years (Required)
• Quality assurance: 5 years (Required)

Work Location: In person