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Director of Quality and Compliance
Primary Job Function
Responsible for product quality engineering activities providing high level of hands-on technical engineering support of the product life cycle, from conception to commercialization and post-market evaluation in a cross-functional environment. Responsible for all aspects related to the quality of Company products, as well as, Quality System processes to establish and maintain compliance to all applicable regulatory requirements. The right candidate has electro-mechanical engineering experience and the ability to take on technical challenges through resolution.
Essential Duties and Responsibilities
- Responsible for assuring projects meet customer expectations, and regulatory requirements including FDA Quality System Regulations 21CFR Part 820, Medical Device Directive (MDD) 93/42/EEC, Canada Medical Devices Regulations (CMDR) (SOR/98-282) and Risk Management per ISO 14971.
- Applies knowledge of IEC 60601-1 Medical Electrical Equipment and collateral standards, IEC 62366 Usability, and IEC 62304 Software Lifecycle to product development and sustained engineering projects
- Develops, maintains, improves, and audits the Quality Management System (QMS) to ensure compliance to applicable FDA and ISO standards
- Serves as Quality Engineering lead for new product development, quality processes improvements, business system implementations or other special projects
- Leads Quality and Compliance activities for Supplier Management related to our products, including qualification of all suppliers and purchased components, conducting supplier quality audits, and establishing outgoing/incoming Receiving Inspection methods, tests, and tools
- Responsible for managing product non-conformances, complaint handling and post-market data collection and analysis, including root causal determination and coordination of associated CAPA, Design Control and Risk Management activities
- Plans, develops, implements, and maintains the Document Change Control system
- Roles and responsibilities may be shifted to maximize customer and Company success
- Bachelor’s Degree in an applied science or engineering field
- 10+ years of experience in Quality Assurance of class II or III with embedded software in the medical device field
- Demonstrated competency of 21 CFR 820, MDD/CMDR, ISO13485, ISO 14971, HIPAA and other international standards
- Ability to work in a fast-paced early-stage startup where “many hats” must be worn
- Exceptional analytical, problem-solving, and interpersonal communication skills
- Understands and can subsequently explain complex quality details to non-experts
- Exceptional organizational skills and attention to detail
- Knowledge and experience with ERP/MRP systems and their applications
- Administrative and financial management skills relative to job expectations
- Willingness to travel when required, up to 40%