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The Design Quality Engineer will be responsible for the quality and regulatory related activities associated with new product development. New product development activities will occur in the contract development context and in the specification developer context. These activities span all aspects of the new product development process. The Design Quality Engineer will advise customers in the contract development context how to incorporate Critical-To-Quality (CTQ) and Design-For-Inspection (DFI) into the development process. The Design Quality Engineer will provide CTQ and DFI input internally while ensuring that Avalign specification development activities conducted by Research and Development (R&D) comply with associated policies, procedures and work instructions as outlined in the design control elements of the Quality Management System (QMS).

The Design Quality Engineer will be responsible to ensure that regulatory compliant technical documentation is compiled and for ensuring the ongoing compliance of the technical documentation for assigned Avalign Technologies design owned products.  The Design Quality Engineer will assist in regulatory filings for Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission. 

A working knowledge of related global design regulations is required. (ISO 13485, ISO 14971, 21 CFR Part 820, and, preferably, EU Medical Device Regulation)  The position requires a hands-on self-directed style, and the ability to influence and effectively communicate vertically, horizontally, across functions, externally with customers and internally with co-workers. The ideal candidate must demonstrate ability to self-direct, strong analytical abilities, and strong verbal and written communication skills.   The position reports directly to the Director of Regulatory Affairs. 

What You Will Do: 

• Responsible for supporting a design control quality system that is complaint to ISO 13485 (latest revision), the Medical Device Directives (while active), and the EU Medical Device Regulations (MDR). 
• Supports, reviews, and approves the following activities associated with new product development: identification and documentation of user needs, design inputs, outputs, verification, validation, risk assessment, and design change activities to demonstrate new product designs are supported by objective evidence in the design history file prior to product launch.
• Participate in supply chain development through Avalign division and external supplier selection and qualification with the new product development team.
• Participates in design reviews as required by the design control and development processes.
• Serve as GD&T expert for contract developer and specification developer activities.
• Assist project managers with design transfer planning and execution including advising on Avalign and vendor manufacturing process validations to support new product development.
• Support processes for Medical Device Reporting and Complaints for Avalign as specification developer products.
• Ensure required design documentation is retained in design history files and technical files to support regulatory submissions and audits.
• Support and maintain all regulatory filings for all Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
• Perform corporate internal audits, either as a supporting auditor or as the lead auditor. 
• Participate in external audits.
• Conduct post market surveillance for contract development and specification developer products.
• Ensure post launch product design file updates are completed following design change and post market surveillance activities.
• Write or update standard operating procedures, work instructions, or policies.
• Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
• Assist in investigations of product complaints, root cause analysis, corrective action, trending and make recommendations regarding their reportability.
• Investigate and complete records related to assigned Nonconformances and CAPAs.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or other compliance issues.

What You Will Need:

• Bachelor degree or equivalent experience in an engineering or scientific field
• 5+ years of experience in quality and/or engineering role
• 2+ years of experience in medical device industry, preferred
• 2+ years of experience in quality within design control activities supporting new product development, preferred
• Experience with ISO 13485, FDA 21 CFR 820 Quality System Regulation, ISO 14971,  MDR, or associated regulations.
• Ability to travel up to 25%

Preferred Qualifications

• Expertise in project management and problem solving skills, including the ability to identify, investigate and resolve technical and/or systemic issues.
• High attention to detail and persistence in resolving discrepancies
• Excellent interpersonal communication (written and verbal) skills and ability to communicate at all levels of the organization and with suppliers and customers
• Familiarity with Quality System Management software
• Familiarity with regulatory submissions including: 
  • Coordinating efforts associated with the preparation of regulatory documents or submissions. 
  • Preparation or review of regulatory submissions for domestic or international projects.