Jobs at Portal Instruments

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.

• Support new product development and product realization through all design control phases. Support verification & validation (test plans, protocols, reports), test method validation.
• Support risk management file generation and maintenance for Portal Instruments products throughout their lifecycle.
• Collaborate with cross-functional teams on design and process related risk management activities.
• Administer Portal’s online document management system and oversee creation, issuance, maintenance, and retention of controlled documents and records.
• Support origination and release of Engineering Change Orders
• Support continuous improvement of quality system procedures in accordance with 21 CFR 820, ISO 13485, EU MDR, MDSAP, and ISO 14971
• Apply statistical methods and process design tools to establish test plans as well as evaluate test data and establish process control
• Lead or participate in 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 

• BS or MS degree in Engineering, Science, or related discipline
• 5+ years of quality engineering 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 using statistical software
• 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
• Document Control experience in medical devices, biotech, or pharma
• Familiarity with electronic document control and PLM systems