Sr. Design Quality Engineer

About the role

Avalign produces innovative, high-performance, and cost-effective medical devices. The Design Quality Engineer will support a design control quality system compliant with ISO 13485, Medical Device Directives, and EU Medical Device Regulations. This role involves supporting new product development, participating in design reviews, assisting with regulatory filings, and conducting post-market surveillance.

Responsibilities

• Supporting a design control quality system compliant with ISO 13485, Medical Device Directives, and EU Medical Device Regulations
• Supporting, reviewing, and approving activities associated with new product development, including identification and documentation of user needs, design inputs, outputs, verification, validation, risk assessment, and design change activities
• Participating in supply chain development through Avalign division and external supplier selection and qualification with the new product development team
• Serving as GD&T expert for contract developer and specification developer activities
• Assisting project managers with design transfer planning and execution, including advising on Avalign and vendor manufacturing process validations to support new product development
• Supporting processes for Medical Device Reporting and Complaints for Avalign as specification developer products
• Ensuring required design documentation is retained in design history files and technical files to support regulatory submissions and audits
• Supporting and maintaining all regulatory filings for all Avalign Technologies design owned products
• Conducting post market surveillance for contract development and specification developer products
• Ensuring post launch product design file updates are completed following design change and post market surveillance activities
• Writing or updating standard operating procedures, work instructions, or policies
• Preparing responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires
• Assisting in investigations of product complaints, root cause analysis, corrective action, trending, and making recommendations regarding their reportability
• Investigating and completing records related to assigned Nonconformances and CAPAs
• Advising project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or other compliance issues

Requirements

• 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
• 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

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