Senior Quality Engineer

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.

Senior Quality Engineer

Report to:

VP, Quality and Regulatory

Key Qualifications

Bachelor’s or Master’s degree in Engineering, Science, or a related technical discipline
5+ years of Quality Assurance or Design Assurance experience within the medical device, biotech, or pharmaceutical industry
Strong working knowledge of quality and regulatory requirements, including 21 CFR 820, ISO 13485, and ISO 14971
Proven experience supporting new product development across all design control phases
Hands-on experience with verification and validation activities, including test plans, protocols, reports, and test method validation
Experience maintaining risk management files and supporting design- and process-related risk management activities
Working knowledge of statistical sampling and data analysis methods
Demonstrated ability to collaborate cross-functionally to translate quality requirements into practical, compliant solutions
Experience supporting corrective and preventive actions (CAPA), root cause investigations, and continuous improvement initiatives
Strong written and verbal communication skills, with the ability to operate effectively in a fast-paced, collaborative environment

Applicants are encouraged to review the full Job Description PDF for complete role details, responsibilities, and preferred qualifications.

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Senior Quality Engineer

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Our values

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.

Senior Quality Engineer