Senior Engineer, Quality

Regulatory Toolkit; Highland (IN); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

None

Job summary

ICU Medical is seeking a Quality Engineer to provide quality support for product development, ensuring compliance with ISO 13485, ISO 14971, 21 CFR Part 820 and related standards. The role covers system, hardware, software and consumable components to ensure the highest level of quality as products are developed.

You will participate in risk analyses, CAPA, design verification, and cross-functional reviews while aligning with development practices.

Qualifications

• Must have a bachelor's degree in engineering or related field.
• ASQ CQE or CSQE certification or ability to obtain within 12 months.
• Experience in medical device quality engineering and regulatory frameworks.

Responsibilities

• Ensure product safety and quality throughout the lifecycle.
• Maintain compliance with ICU Medical quality system and development practices.
• Utilize quality tools for risk analysis, validation, V&V and CAPA.
• Prepare for internal/external audits and inspections.
• Lead design reviews, risk assessments, and cross-functional collaboration.
• Review qualification of software and software tools.
• Support regulatory submissions and inquiries.

Skills

Quality compliance

Audit skills

Investigation skills

Quality management systems

Risk management

Cross-functional teamwork

Design controls

Education

Bachelor's degree in engineering

ASQ CQE or CSQE certification

Tools

CAPA systems

Audit management tools

Job description

Position Summary

Provide quality support and assurance for ICU Medical product development. The Quality Engineer will be responsible for development procedures and deliverables, ensuring their compliance with ICU Medical quality system requirements and applicable regulations and standards (such as ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable regulations and standards). The Quality Engineer will provide quality assurance support for product realization/manufacturing teams for the system (includes aspects of electro-mechanical, software and consumable components) product lines. This individual will be the Quality Core Team Member for ensuring products are developed/manufactured utilizing appropriate processes to design the highest level of quality into products as they are developed.

Essential Duties & Responsibilities

• Ensure the safety of products developed by managing the product life cycle activities to meet the quality system requirements.


• Ensure compliance, alignment and consistency with ICU Medical’s quality system and development practices.


• Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality.


• Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections.


• Perform periodic audits of projects against SOP’s and process.


• Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, code review, and unit test inspections.


• Review, approve and participate in qualification of acquired software and software tools.


• Perform and support product risk analysis and management.


• Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc.


• Monitor product data to identify statistically significant trends and risks.


• Support on-market issue investigations, risk assessments and associated CAPA activities.


• Review and approve resolution of on-market product issues.


• Support regulatory submissions and responses to regulatory inquires.


• Work special projects as assigned

Knowledge & Skills

• Expert quality compliance, audit, and investigation skills


• In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)


• Strong knowledge of medical device standards, including but not limited to:
  
  
  
  • ISO 13485
  
  
  • ISO 14971
  
  
  • IEC 60601
  
  
  • IEC 62304
  
  
  
  


• In depth experience with and knowledge of FDA, MDR, and other key medical device regulations


• Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)


• Proven ability to work closely with engineering teams and members of a cross functional team


• New product development experience is strongly preferred.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age


• Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, Software) or related field from an accredited college or university is required.


• Minimum of 7+ years of experience in quality engineering, product design or product engineering in the medical device industry


• ASQ CQE or CSQE required or the ability to obtain within one year.

Work Environment

• This is largely a sedentary role.


• This job operates in a professional office environment and routinely uses standard office equipment.


• Typically requires travel 5% to 10% of the time