Quality Systems Engineer

We are seeking a highly organized and adaptable professional to support our medical device development and quality operations. This role is ideal for a jack‑of‑all‑trades who enjoys creating order, connecting cross‑functional efforts, and ensuring that studies, documentation, and processes run smoothly across multiple domains. You will play a key role in structuring our studies and results, strengthening our Quality Management System (QMS), supporting validation activities, and driving overall operational excellence across R&D, Quality, and Regulatory functions.

• Develop and maintain systems for organizing preclinical, clinical, and engineering study data and reports.
• Track study progress, deliverables, and timelines; ensure results are documented and accessible.
• Support coordination between internal teams and external partners.
• Assist in the maintenance and continuous improvement of the QMS in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Help manage document control, training records, and CAPA tracking.
• Participate in internal audits and regulatory inspection readiness activities.
• Coordinate and document validation efforts (equipment, software, and process validations).
• Support test plan creation, protocol execution tracking, and results compilation.
• Work with technical teams to ensure traceability and compliance of all validation activities.
• Create and refine processes for project tracking, reporting, and information flow across teams.
• Identify opportunities for efficiency and standardization.
• Maintain dashboards or summaries of study and quality program status for management review.

• Bachelor's degree in engineering, Life Sciences, Quality Management, or related field.
• 3+ years of experience in medical device, biotech, or related regulated industry.
• Broad understanding of quality systems, validation, and documentation processes (not necessarily deep expertise in one area).
• Strong organizational and project management skills with keen attention to detail.
• Excellent communication and collaboration abilities.
• Comfortable working in a dynamic, cross‑functional environment.
• Familiarity with ISO 13485, FDA QSR, and risk management principles (ISO 14971).
• Experience with QMS software, document control systems, or electronic validation tools.
• Ability to translate complex technical information into clear, structured documentation.
• A proactive mindset and natural inclination toward order, structure, and follow‑through.

Associate

Contract

Quality Assurance

Pharmaceutical Manufacturing