Quality & Regulatory Engineer
Position: Quality & Regulatory Engineer
Location: North Tonawanda, NY
Role Type: Full Time
Remote/In-Office: In-Office
NOVAIR – Simplifying Oxygen, Nitrogen and Medical Gases
About NOVAIR
NOVAIR USA Corporation, a member of family owned, Paris-based NOVAIR Groupe, is headquartered in North Tonawanda, New York, USA, between Niagara Falls and Buffalo. Novair is recognized as a global leader in the manufacturing of oxygen and nitrogen generating systems for industrial and medical applications.
Novair-USA is developing the ION (www.ionicoxygen.com), a cutting-edge technology in a joint venture with American Oxygen (AMOX) and strives to utilize this proprietary technology in commercializing a scalable, sustainable, low-cost system for on-site generation of ultra-high purity oxygen. Through this Joint Venture we will design a full family of commercial solutions that are environmentally friendly, meet the needs of each customer in the industries we serve and benefit the overall communities that we sell and operate in.
NOVAIR USA Vision, Mission, and Values
- NOVAIR USA’s MISSION – NOVAIR USA Corporation provides reliable onsite gas generating solutions to save lives and improve industrial processes worldwide.
- NOVAIR USA’s VISION – To be the world’s top-ranked onsite healthcare and industrial gases provider in quality, customer, and employee satisfaction.
- NOVAIR USA’s VALUES – NOVAIR employees have CHARM:
– Customer-centric
– Honorable
– Accountable
– Reliable
– Motivated
Position Overview
Roles and Responsibilities
- Review design history technical files for conformance to applicable requirements and regulatory standards.
- Review design changes to ensure documentation includes necessary justifications, validation and verification updates, risk assessment, etc.
- Review all applicable design documentation (verification & validation protocols/reports, DRTM, FMEAs, design outputs, etc.)
- Support Manufacturing line, investigate and address quality issues.
- Conduct internal, vendor and process audits
- Interface with suppliers to resolve quality issues
- Responsible for document change requests, CAPAs, NCRs, temporary deviations, Equipment management, and defining & maintaining training of personnel on all aspects of the Quality System and regulatory standards
The Skills You Bring
- 5+ years of Quality Engineering experience preferably with technical knowledge and experience in Quality Assurance and/or regulatory functions in the medical device industry
- Bachelor’s Degree in Mechanical or Biomedical Engineering or related engineering or scientific disciplines.
- ISO 9001, ISO 13485 and cGMP/21 CFR 820 experience required
- Strong self-starter, effective team player
- Effective oral, written and presentation skills
- Knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Teams)
Total Rewards
- Health & Wellness: Multiple Medical, Dental, and Vision plans to meet your specific needs.
- Future Planning: Market Competitive 401K + Matching Contribution
- Time Off: Including Vacation + Sick Time
- Employee Assistance Program, Travel Reimbursement (for qualifying roles), and more.