Manager, Quality System

THE COMPANY: Novian Health is a medical device company headquartered in Chicago. The company has developed technology for the focal destruction of tumors using Interstitial Laser Therapy. Novilase® Breast Therapy uses controlled heating with a laser to destroy breast tumors as a minimally-invasive alternative to surgery. It is more effective while providing a much better patient experience.

We want to improve breast care for millions of women – join the team!

With its recent CE Mark, the Company plans to initiate European commercial operations in 2022. In the U.S., Novilase is cleared to treat fibroadenomas and the Company is preparing to launch a multi-center pivotal trial in the U.S. and Europe to support U.S. approval for malignant breast tumors. Other indications will follow.

RESPONSIBILITIES:

Maintain a Quality System in compliance with FDA, QSR, MDD/MDR and ISO regulations. Ensure continued Product CE Certifications. Maintain and work to continually improve the quality system in conjunction with senior management. Provide input to Company’s regulatory strategy. Responsible for interactions with U.S. and international regulatory authorities, and managing regulatory support, including auditors, software, and other support vendors.

Specific Duties:

• Maintains product and Company compliance with federal and state regulations, as well as rules and regulations specific to the medical device industry.
• Maintains compliance with FDA, QSR, MDD/MDR, and ISO 13485 requirements, including preparing for and leading successful audits.
• Manages Quality Management System throughout the product development lifecycle.
• Assist with preparation of regulatory submissions.
• Contribute to Clinical Affairs by supporting the collection of clinical data and generating data for marketing, reimbursement, and regulatory purposes.
• Support company goals, objectives, policies, and procedures as required by QSR, FDA, and other regulations. Provide support to marketing, sales, and other areas of the business as directed
• Manage ongoing solutions to production-related issues that include CAPA’s, Quality Plans, Quality Reviews, Design Reviews, Change Orders, Specification Exceptions, etc.
• Be responsible for implementing policies and procedures for managing and monitoring all contractors, subcontractors and suppliers.
• Verify that all proper policies and procedures in our existing QMS are being followed by all parties.
• Support company goals, objectives, policies, and procedures as required by QSR, FDA, and other regulations. Provide support to marketing, sales, and other areas of the business as directed
• Maintain current knowledge of European, Federal, and State regulations regarding design and manufacturing of medical devices, and their impact on the Quality Management System.
• Excellent leadership, management, collaboration, and decision-making skills.
• Ability to travel 30%
• Contributes to team effort and can deliver against tight deadlines, with moderate budgets, and in a high technology field.

SKILLS/QUALIFICATIONS:

1. Bachelor’s degree in life sciences, engineering, or equivalent.

2. The most qualified individual will have 10-15 years experience in quality system management in U.S. and Europe, preferably in the medical device field, have used or will be able to utilize electronic QMS and other automated systems.

3. Solid understanding of U.S. and European medical device regulations, political and legal climate, and industry practices to assist in meeting organizational goals. Possess and can leverage broad industry knowledge.

4. Attention to detail, emphasizing excellence and innovation.

5. Ability to work well in an unstructured, fast-paced environment.

For company information, please see www.novianhealth.com

Bonus plan and competitive benefits included.

Job Type: Full-time

Pay: $75,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Quality management: 10 years (Required)
• eQMS: 4 years (Preferred)

Ability to Relocate:

• Chicago, IL 60654: Relocate before starting work (Required)

Work Location: In person