Quality Engineer II - ICU Sustaining & Validation

Regulatory Jobs; Salt Lake City (UT); In loco; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Regulatory Jobs is seeking a Quality Engineer II, Sustaining to ensure ICU product processes, equipment and software meet quality and regulatory standards. You will validate equipment, processes, and software, collaborating with R&D, manufacturing and QA teams to maintain compliance.

The role requires experience in regulated environments, capability with validation activities (IQ/OQ/PQ), and knowledge of FDA 21 CFR Part 820, ISO 13485 and ISO 14971. A strong problem-solving mindset is essential.

Competenze

• Bachelor's degree in STEM from an accredited college or university.
• 2-4 years’ experience working in a regulated manufacturing or pharmaceutical/healthcare environment.
• Proficiency in using validation software and other relevant tools (e.g., Minitab).
• Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485).

Mansioni

• Demonstrate understanding of changes to critical process in manufacturing and testing of ICU products.
• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, processes, and software systems.
• Conduct risk assessments to identify CQAs and CPPs for validation.
• Create and review Quality Control Plans and process FMEA’s.
• Ensure validation documentation is accurate and compliant with regulatory and quality system requirements.
• Maintain validation master plans, protocols, and reports as part of the company’s quality system documentation.
• Improve the Quality Management System through internal audits and supporting regulatory audits.
• Lead and support validation of new and existing manufacturing processes across regulatory requirements (FDA, ISO).
• Develop and execute Test Method Validations for manufacturing processes and lab equipment.
• Apply engineering principles to analyze and resolve problems of moderate complexity.
• Write reports promptly and effectively in a team with shifting priorities.
• Update SOPs and QMS documents to drive improvement projects.
• Establish internal and external communication with customers, molding, automation, assembly, product engineering, PM and regulatory personnel.
• Continually improve knowledge of quality/regulatory topics and changes.

Conoscenze

Agile PLM / Oracle

GD&T

Minitab

Microsoft Office

Communication

Multitasking

Attention to detail

Formazione

Bachelor's degree in STEM

Strumenti

Minitab

Microsoft Office Suite

Descrizione del lavoro

Regulatory Jobs is seeking a Quality Engineer II, Sustaining to ensure ICU product processes, equipment and software meet quality and regulatory standards. You will validate equipment, processes, and software, collaborating with R&D, manufacturing and QA teams to maintain compliance.

The role requires experience in regulated environments, capability with validation activities (IQ/OQ/PQ), and knowledge of FDA 21 CFR Part 820, ISO 13485 and ISO 14971. A strong problem-solving mindset is essential.