Quality Assurance Manager

2 weeks ago

Santa Clara, United States Lumenous Device Technologies Full time

**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 mínimally 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.

**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

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