Quality Engineer to be part of a small and nimble Quality and Regulatory group that is creating revolutionary devices to improve sample collection and integrity for critical in-vitro diagnostic (IVD) tests. Implementing our Product Reliability Program and managing associated sustaining activities assuring ongoing compliance and professional growth in the medical device and compliance disciplines. Sustaining activities are critical to compliance and are an entry point for product development and improvement. Through a series of product testing, document authorship, and collaboration with multi-departmental stakeholders from Product Development, Manufacturing Operations, and Quality, this role offers a unique opportunity for career development in a regulated environment.

The Quality Engineer is responsible for supporting the development, implementation, and maintenance of the Quality Management System in compliance with FDA, ISO 13485, and applicable global regulatory requirements. This role is highly hands-on and ideal for someone who thrives in a fast-paced startup environment and enjoys improving processes.

Responsibilities and Duties:

Quality System & Compliance

• Support implementation and maintenance of the QMS compliant with ISO 13485, 21 CFR Part 820, and other applicable standards
• Author, review, and maintain quality documents (SOPs, work instructions, forms, records)
• Support internal and external audits, including FDA inspections and notified body audits
• Assist with Management Reviews and quality metrics reporting

Design & Development Support

• Support Design Controls activities (requirements, risk management, verification & validation)
• Participate in risk management (ISO 14971) activities, including FMEA and hazard analysis
• Review design documentation for compliance and completeness
• Assist as needed with Test and Inspection

Manufacturing & Supplier Quality

• Review and approve process validation, including IQ/OQ/PQ activities
• Assist and/or lead supplier qualification, audits, and supplier corrective actions
• Review incoming inspection plans and ensure manufacturing controls are effective

CAPA, NC, and Continuous Improvement

• Manage complaint handling procedure
• Lead or support CAPA, nonconformance, and deviation investigations
• Perform root cause analysis and verify effectiveness of corrective actions, both QMS and customer complaints
• Drive continuous improvement across quality processes

Experience and Qualifications:

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or related field
• 2-5 years of quality engineering experience in the medical device or regulated industry
• Working knowledge of ISO 13485, FDA QSR (21 CFR 820), and design controls
• Experience with CAPA, audits, document control, and risk management
• Strong written and verbal communication skills

Preferred Qualifications:

• Experience in an early-stage or startup environment
• Familiarity with ISO 14971, MDR, or global regulatory requirements
• Experience supporting V&V, process validation, or supplier audits
• CQE, CQA, or similar certification