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This role is central to advancing Portal’s PRIME Nexus® platform toward commercialization. Working cross-functionally with engineering, regulatory, manufacturing, and external partners, the Quality Engineer will represent Quality across design and manufacturing activities, supporting quality systems, verification and validation, process validation, customer feedback, and CAPA. This is a high-impact opportunity to take ownership, solve complex problems, and contribute meaningfully at a pivotal stage of Portal’s growth.
What You’ll Do
Your Impact
• Contribute directly to the development, validation, and commercialization of Portal’s
drug-delivery platforms
• Collaborate across disciplines to solve complex technical and operational challenges and
translate requirements into practical, compliant solutions
Key Responsibilities
• Support new product development and product realization through all design control phases.
Support verification & validation (test plans, protocols, reports), test method validation,
incoming inspection, lot release of engineering, clinical and commercial devices, nonconforming
product disposition, review of design documentation, calibration and equipment validation
(IQ/OQ/PQ)
• Maintain the risk management file for Portal Instruments products throughout their lifecycle.
Collaborate with cross-functional teams on design and process related risk management
activities.
• Work with software team to support device software development, verification, and release in
compliance with IEC 62304 and relevant regulatory requirements
• Support continuous improvement of quality system procedures in accordance with 21 CFR 820,
ISO 13485, EU MDR, MDSAP, and ISO 14971
• Lead corrective and preventive processes as required, including documentation of CAPA, root
cause investigation, and implementation of improvement activities
• Conduct and/or participate in internal and external audits as needed
• Partner cross-functionally to translate quality requirements into practical, compliant solutions
• Act as subject matter expert for quality engineering practices
• Partner with Engineering and Operations to ensure designs are effectively transferred to
manufacturing
• Engage with internal and external stakeholders, including vendors and partners
• Foster collaboration, cross-functional communication, and risk-based decision making
What We’re Looking For
Required Qualifications
• BS or MS degree in Engineering, Science, or related discipline
• 5+ years of quality assurance or design assurance experience in the medical device, biotech, or
pharmaceutical industry
• Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971
• Proven track record supporting new product development
• Knowledge of statistical sampling and data analysis methods
• Ability to work effectively in a fast paced, collaborative environment
• Strong communication skills and comfort working cross functionally
Preferred Qualifications
• Experience with drug-device combination products and working knowledge of relevant
standards (e.g. ISO 11608)
• Knowledge and experience with MDSAP, EU MDR, IEC 62304, and ISO 60601
• Exposure to human factors engineering, usability, or patient centric design
• Experience supporting products through development, validation, and commercialization
• Experience working with contract manufacturers and establishing relationships with suppliers
Portal Instruments is committed to challenging implicit bias and creating an equitable work environment. We are proud to be an equal opportunity employer. All qualified candidates will receive consideration without regard to race, ethnicity or national origin, sexual orientation, gender identity or expression, genetics, military service, age, family status, or disability.
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