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Principal Engineer, Quality Systems

2 months ago


Lake Forest, Illinois, United States Smiths Medical Full time
Position Overview
As a pivotal member of the quality team at Smiths Medical, the Senior Quality Engineer will provide essential support for the development and quality assurance of medical hardware. This role is critical in ensuring that all procedures and deliverables meet the stringent requirements of our quality management system and comply with relevant regulations and standards, including ISO 13485, ISO 14971, and 21 CFR Part 820.

Key Responsibilities

The Senior Quality Engineer will:

  • Utilize advanced quality tools and methodologies such as risk management, validation, and design verification to uphold product quality.
  • Ensure compliance with FDA regulations and international standards, assisting in communications with regulatory bodies regarding medical device compliance.
  • Provide expert guidance on the development and maintenance of quality standards throughout the product lifecycle.
  • Collaborate with cross-functional teams to manage product modifications effectively.
  • Engage in design reviews, risk assessments, and other critical evaluations to support product development.
  • Offer corporate quality support and strategic direction to resolve on-market product issues, escalating matters to senior management as necessary.
  • Continuously assess product and process risks, implementing improvements to enhance overall quality.
  • Analyze data from various sources, including product reviews and manufacturing quality metrics, to identify trends and potential risks.
  • Prepare for and facilitate internal and external audits and inspections, ensuring readiness and compliance.

Qualifications

The ideal candidate will possess:

  • A Bachelor's degree in Engineering (Electrical, Mechanical, Biomedical) or a related field; a Master's degree is preferred.
  • A minimum of 7 years of experience in Research & Development or Quality Assurance.
  • ASQ CQE certification or the ability to obtain it within one year.
  • In-depth knowledge of Quality Management Systems and experience in linking risk management to quality system elements.
  • Strong familiarity with medical device standards and regulations, including ISO 13485, ISO 14971, and IEC 60601.
  • Proven ability to collaborate effectively with engineering and manufacturing teams.

Work Environment

This role is primarily sedentary and operates within a professional office setting, utilizing standard office equipment. Travel requirements are minimal, typically ranging from 5% to 10%.


Equal Opportunity Statement

Smiths Medical is committed to fostering an inclusive workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.