Design Quality Manager

Provide Design Quality leadership and guidance for product development (includes LDT and IVD), design control (e.g., design and development planning, training, design input, design output, design review, design verification, design validation, design transfer, product design changes, and design history file (DHF)), risk management, change management, process validation/controls, and equipment qualification.  

Provide Design Quality leadership and guidance for IVD product development in compliance with FDA 21 CFR 820 QMSR/ISO 13485 

Support the development teams in aligning our product development execution strategy with Design Control and Risk Management procedures

Provide guidance, training, review, approve user needs, design input, design control plans, requirements, specifications, protocols/reports, design outputs, design transfer, and risk management documents.

Lead in partnership with the cross-functional team by facilitating and supporting risk activities, including FMEAs- dFMEA, pFMEA, and use-related risk analysis- from hazard identification through risk control verification and residual risk evaluation. Own the Risk Management Plan and Report, support cross-functional working sessions to current and complete state, and ensure risk file linkage to design outputs, V&V evidence, and labeling.

Provide support for the preparation of PMA modules/documents and supporting documents to be submitted- including design control and risk management content, and assist in responding to FDA information requests in those areas.

Drive cross-functional alignment on design documentation. Set consistent standards for the quality of document types, content, lexicon, and level of detail. Ensure DHF design control evidence is submission-ready as it's generated; track/monitor oversight of documentation progress against timelines accordingly

Lead remediation of existing design and risk documentation. Assess previously created design control and risk management documents and align according to established procedures, design documentation strategy, and documentation standards.

Support the development teams in aligning our product development execution strategy with our Design Control and Risk Management procedures.  Review, approve, and audit Design History File (DHF) elements (e.g., plans, requirements, specifications, test protocols/reports, design traceability, and risk management documents).

Maintain the section-level inventory of every document required in the DHF, mapped to ISO 13485 with named author, reviewer, approver, and due date for each.

Review and approve design control, risk management, product change management, production, verification/validation, equipment qualification documents per applicable regulatory requirements and company procedures.

Provide support for the preparation of pre-submissions, sprints, and PMA modules/documentation.  

Train and mentor cross-functional peers and junior team members on best practices for maintaining compliance with the applicable Quality Management System (QMS) requirements and regulations.