Quality Systems Engineer, Design Controls

PECA Labs is a medical device company developing next-generation cardiovascular devices designed to improve outcomes for patients with complex cardiac and vascular needs. Our work spans polymeric vascular grafts, heart valves, and related implantable technologies. We are looking for a detail-oriented, systems-minded quality professional to help strengthen and document the design-control processes that support the evolution of PECA devices from concept through development, verification, validation, regulatory submission, and commercialization.

PECA Labs is seeking a Quality Systems Engineer, Design Controls to create, organize, and maintain quality-system documentation related to the design and development of PECA medical devices. This role will focus on documenting how PECA’s design processes evolve over time, ensuring that design history, design changes, risk management, requirements, verification, validation, and related quality records are clear, traceable, compliant, and inspection-ready.

The ideal candidate understands medical device design controls, enjoys building structured documentation systems, and can work cross-functionally with engineering, quality, regulatory, manufacturing, and clinical teams. This person should be comfortable translating technical design activity into clear quality-system records that support ISO 13485, FDA QMSR, and internal quality requirements.

• Develop, revise, and maintain quality-system documentation related to PECA’s design and development processes, including design control procedures, work instructions, templates, design plans, design review records, design change documentation, and Design History File records.
• Document the evolution of PECA device designs and related development processes in a clear, traceable, and audit-ready manner.
• Partner with engineering and product development teams to capture design inputs, design outputs, design reviews, design verification, design validation, design transfer, and design changes.
• Support creation and maintenance of Design History Files, Device Master Record inputs, risk management files, traceability matrices, and related quality records.
• Ensure documentation accurately reflects current design practices while preserving historical design rationale, decision-making, and change history.
• Help establish scalable documentation structures for new and evolving PECA devices, platforms, and product families.
• Review design and quality records for completeness, consistency, compliance, and traceability.
• Work with Quality and Regulatory teams to ensure documentation aligns with ISO 13485, FDA QMSR, applicable regulatory expectations, and PECA’s internal quality management system.
• Support design reviews, risk reviews, audits, inspections, and regulatory submissions by preparing and organizing relevant documentation.
• Identify gaps in existing design-control documentation and recommend practical improvements to processes, templates, workflows, and records.
• Collaborate with cross-functional teams to standardize how design evolution, engineering decisions, requirements changes, and risk-control updates are documented.
• Support change control activities related to product design, process updates, quality-system documents, and design records.
• Contribute to a culture of quality, patient safety, documentation discipline, and continuous improvement.