The Role

This is a senior-level position that is responsible for the quality engineering oversight of design control and, operations and risk management activities for medical devices manufactured by ExThera Medical. This individual will work closely with product development teams, manufacturing, suppliers, and testing partners throughout the entire device life cycle. This role oversees the development, implementation, and continuous improvement of device-related quality processes and procedures and ensures compliance with the relevant standards and regulatory requirements for devices

A Few Key Responsibilities

• Provides input for the development of quality standards and/or specifications and procedures relative to packaging, handling, logistics operations, testing, inspection and manufacturing.
• Support the maintenance of Risk Management File, identifying high risk/high reward opportunities and betting boldly, but not recklessly, on them.
• Understand and deploy processes to assure conformance to government regulations, industry standards and product specifications.
• Reviews verification and validation protocols and reports for R&D and Manufacturing and ensures documentation is written according to the QMS.
• Provides input to process manufacturing design and design transfer to ensure compliant, robust product realization.
• Implementation of Production and Process Controls including but not limited to pFMEAs, Master Validation Plans, Process Validations, critical component evaluations, quality inspections, facility validation activities, etc.
• Improvement and optimization of quality processes.
• Supports internal and external audits and inspections as a device Subject Matter Expert.
• Experience in supplier management and relations, including quality agreement generation and maintenance.
• Real-time oversight over change control including product design changes, product requirements, human factors engineering, design verification, design validation, manufacturing process changes, and supplier-initiated changes.
• Plan, conduct and lead supplier audits with respect to product design and raw materials.
• Ability to effectively influence others without direct authority and professionally handle conflict resolution.
• Other duties as assigned.

What You Bring

• Minimum Bachelor’s degree in an Engineering or Applied Sciences discipline.
• Minimum 10 years of substantially related experience in either quality, operations, engineering, or a combination thereof; with at least 8 years of medical product Quality
• Assurance with firm knowledge of regulations.
• Intimate knowledge of a quality management system compliant with 21CFR Part 820 and ISO 13485 is required. Experiences such as setting up a quality system and deep knowledge of product quality from design and manufacturing viewpoints is essential.
• High analytic skills to propose compliant and pragmatic regulatory strategies.
• Ability to work in a regulated environment in compliance to ISO 13485:2016, US CFR, MDD/MDR, CMDR, MDSAP and all other applicable regulations.
• Must be able to review multiple submissions, regulatory assessment, and strategies for ExThera’s success internationally.
• Requires strong written, verbal, and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.
• Ability to translate and simplify problems of considerable scope and complexity into manageable tasks with measurable requirements.
• Ability to drive collaboration, create high level of teamwork, and evaluate a positive culture cross-functionally.
• Integrates and demonstrates core values, integrity, and accountability.
• Team player, resourceful and conscientious, detail oriented and professional.
• Must be easily adaptable to changing priorities and deadlines.