Senior Quality Engineer

This role is a critical part of Portal’s mission to advance PRIME Nexus® toward commercialization. You will work cross‑functionally with engineering, regulatory, manufacturing, and external partners to help scale a novel drug‑delivery platform that directly impacts patient experience and therapeutic success. This role will support quality processes for medical device development and manufacturing at Portal Instruments. The QE will represent Quality on internal and external project teams for both design and manufacturing. This role will support quality systems, document control, product design verification & validation, manufacturing process validation, customer feedback, and corrective and preventive action investigations and implementation. This is an opportunity to take ownership, solve complex problems, and contribute meaningfully at a pivotal stage of Portal’s growth.

Senior Quality Engineer

Report to:

Quality Assurance Manager

Key Qualifications

Bachelor’s or Master’s degree in Engineering, Science, or a related technical discipline
5+ years of quality engineering experience in 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
Knowledge of statistical sampling and data analysis methods using statistical software
Ability to work effectively in a fast paced, collaborative environment
Strong communication skills and comfort working cross functionally

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

‍

Application form

Please submit your information.

You're applying for:

Senior Quality Engineer

Thank you!
‍
Your submission has been received!
‍
You will be contacted if your background meets Portal’s needs.

Oops! Something went wrong while submitting the form.

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