Responsibilities:

Serve as the Design Control subject matter expert and advise product teams on the application of Noctrix SOPs, applicable regulatory requirements, and design control best practices Act as the lead Quality representative for new product development and sustaining product changes involving hardware, firmware, software, labeling, components, suppliers, and related manufacturing updates Guide project teams through design planning, design inputs, design outputs, design reviews, design verification, design validation, design transfer, design changes, traceability, and risk management activities Review proposed product changes and advise teams on the appropriate design control, risk management, verification, validation, and documentation requirements Participate in project planning, design reviews, change reviews, and cross-functional technical discussions as the Quality representative Provide Quality Engineering guidance on verification and validation strategies, protocols, reports, acceptance criteria, traceability, risk assessments, and change implementation plans Lead Quality Engineering activities associated with manufacturing updates resulting from new product development and sustaining product changes Coordinate with Engineering, Operations, Manufacturing, contract manufacturers, suppliers, and external partners to ensure product changes are implemented effectively and compliantly Support supplier, component, and manufacturing changes that may impact product design, safety, performance, regulatory requirements, or manufacturing implementation Support CAPA and nonconformance activities, including investigation planning, root cause analysis, corrective action development, implementation, and effectiveness evaluation Own or support risk management activities and documentation for Class II or higher medical devices Review and approve design control, verification and validation, engineering change, risk management, and manufacturing implementation documentation Identify process roadblocks, compliance risks, unclear requirements, and inefficiencies affecting NPD, sustaining activities, and product change implementation Recommend and support practical improvements to design control, change management, risk management, verification and validation, and product development processes Serve as a Design Control SME during internal audits, external audits, certification audits, regulatory inspections, and Quality System readiness activities Provide technical guidance and mentorship to Quality personnel and cross-functional teams Promote consistent application of Design Control and Quality Engineering best practices across the organization

Requirements:

Bachelor's degree or higher in Engineering, Life Sciences, Quality, or a related technical discipline Minimum of 6 years of Quality Engineering experience within the medical device industry Significant experience supporting new product development and sustaining product changes Strong working knowledge of FDA Design Control and Quality System requirements, ISO 13485, ISO 14971, risk management, verification and validation, design transfer, and change control Demonstrated experience serving as a Design Control SME and advising cross-functional teams on regulatory requirements, company procedures, documentation expectations, and best practices Experience supporting medical device development and product changes involving hardware, firmware, software, labeling, components, suppliers, and manufacturing updates Experience owning or managing risk management documentation for Class II or higher medical devices Experience reviewing or approving Design Control, verification and validation, engineering change, and manufacturing implementation documentation Experience supporting Design Transfer and manufacturing implementation activities Experience leading or supporting CAPA and nonconformance investigations, root cause analysis, corrective actions, and effectiveness evaluations Strong understanding of the relationship between product risk, design controls, manufacturing changes, and regulatory compliance Strong analytical and problem-solving skills with the ability to identify compliance risks and recommend practical solutions Excellent technical writing, documentation, facilitation, and communication skills Strong organizational skills with the ability to independently manage multiple complex priorities Demonstrated ability to influence and guide cross-functional teams without direct authority

Preferred Qualifications:

ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or similar professional certification Experience with therapeutic wearable, connected medical device, or electro-mechanical medical device products Experience supporting software and firmware development within a medical device Design Control environment Experience working directly with contract manufacturers and external development partners Experience supporting FDA inspections, ISO 13485 certification audits, or other regulatory inspections Experience with supplier quality and component qualification activities Experience mentoring Quality Engineers or serving as a technical leader within a Quality organization Experience working within a high-growth medical device organization

Compensation:

Base Pay:

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Senior Quality Engineer