Position Summary
This role is critical to ensuring that all processes, equipment, and systems involved in the manufacturing and development of ICU Products meet the highest standards of quality and regulatory compliance. The Quality Engineer II, Sustaining will work closely with cross-functional teams, including R&D, Advanced Manufacturing Engineering, Manufacturing, and Quality Assurance, to validate equipment, processes, and software used in production.
Essential Duties & Responsibilities
- Demonstrate an understanding and functional impact of changes to critical process in the manufacturing and testing of ICU products.
- Develop and execute validation protocols (IQ/OQ/PQ) for manufacturing equipment, processes, and software systems.
- Conduct risk assessments to identify critical quality attributes (CQAs) and critical process parameters (CPPs) for validation.
- Create and review Quality Control Plans and process FMEA’s,
- Ensure validation documentation is accurate, complete, and in accordance 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 the validation of new and existing manufacturing processes, ensuring compliance with FDA regulations, ISO 13485 standard, and company quality systems.
- Develop and execute Test Method Validations for manufacturing processes and laboratory equipment, as needed
- Must be able to apply a well-rounded understanding of engineering/design specifications, and engineering principles and methods, to perform analysis and resolve problems of moderate complexity.
- Write effective reports and do so in a timely, priority driven manner, working effectively in a team environment with shifting priorities and time sensitive requirements.
- Updates Standard Operating Procedures and related QMS documentation, to complete improvement projects, as required.
- Establish and maintain communication both internal and external (with the customers, molding, automation, assembly, product engineering, project management and regulatory personnel as needed)
- Continually improve knowledge of relevant quality/regulatory topics and changes.
Knowledge, Skills & Qualifications
- Knowledge of Agile PLM / Oracle (Desirable)
- Knowledge of basic Geometric Dimensioning & Tolerancing (GD&T) concepts.
- Proficient in Minitab and Microsoft Office Suite
- Strong communication skills and the ability to work collaboratively with cross-functional teams.
- Able to multitask and work in a fast-paced environment.
- High level of attention to detail and strong organizational skills.
Education and Experience
- Must be at least 18 years of age
- Bachelor’s degree in STEM from an accredited college or university
- 2-4 years’ experience working in a regulated manufacturing or pharmaceutical/healthcare environment required. Prior experience in quality is preferred.
- Proficiency in using validation software and other relevant tools (e.g., Minitab, statistical analysis software).
- Strong knowledge of medical device validation processes, risk management, and regulatory requirements (FDA 21 CFR Part 820, ISO 14971, ISO 13485).
Physical Requirements and Work Environment
- This is largely a sedentary role.
- This job operates in a professional office environment and routinely uses standard office equipment.
- Work is partly performed in a clean room environment
- Must be able to occasionally move and lift objects of up to 25 lbs
- Typically requires travel less than 5% of the time