Talent.com
Quality Engineer II
Quality Engineer IIMedical Murray • Lake Zurich, IL, US
Quality Engineer II

Quality Engineer II

Medical Murray • Lake Zurich, IL, US
28 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

About the Role

We are seeking a driven and detail-oriented Quality Engineer II to join our team. This role plays a key part in ensuring our products and processes meet the highest standards of quality, safety, and compliance . You will be engaged in technical quality activities, continuous improvement projects, and cross-functional collaboration, helping to deliver goods and services that meet our customers’ expectations for quality, quantity, and timeliness .

If you are looking for an opportunity to grow your career, bring your expertise to the next level, and make a direct impact on product quality and patient safety, this position may be a great fit.

Key Responsibilities

  • Enforce and support the Quality Management System and applicable SOPs.
  • Perform, review, and approve testing and inspection activities, including training quality inspectors and technicians.
  • Develop and implement solutions that streamline and improve quality processes .
  • Support calibration and preventative maintenance of gauges and equipment.
  • Optimize inspection methods, sampling plans, and documentation processes.
  • Review and approve manufacturing documentation and engineering changes to ensure compliance and proper justification.
  • Support production inspections, evaluate nonconforming parts, and complete nonconformance reports.
  • Partner with process owners to resolve nonconformances and drive corrective and preventive action (CAPA) activities.
  • Author and execute validation protocols and reports, including process, software, and test method validations.
  • Support and participate in internal, external, and supplier audits as well as follow-up actions.
  • Review and approve sterilization cycle results and support cycle validations where applicable.
  • Leverage ERP systems to drive quality improvements and efficiencies.
  • Provide overall quality and production support to meet business objectives.
  • Monitor and report on quality trends and performance indicators.

Qualifications & Skills

  • Education : BS in Engineering or equivalent experience.
  • Experience :

    • Minimum 3 years of experience in Quality Engineering for medical devices or 5+ years in quality roles overall.

  • Knowledge of ISO-13485 and FDA 21 CFR Part 820 cGMP standards.
  • Quality assessment and audit experience preferred.
  • Technical Skills :

    • Strong knowledge of disposable medical device testing, validation protocols, and report writing.

  • Experience with statistics, including SPC and design of experiments.
  • Proficiency in Microsoft Office or equivalent software.
  • Other Skills :

    • Excellent communication (written and verbal).

  • Strong analytical and problem-solving abilities.
  • Six Sigma Green Belt certification desired.

    • Why Join Us?

  • Be part of a mission-driven team working to ensure safe and effective medical devices reach patients.
  • Enjoy opportunities to lead and participate in continuous improvement projects that directly impact operations.
  • Collaborate with talented colleagues in a supportive, growth-focused environment .
  • Competitive compensation and benefits designed to support both your career and personal goals.

    • Apply Today

    If you are passionate about quality, eager to bring new ideas, and ready to make an impact, we invite you to apply and join our team as a Quality Engineer II .

    Create a job alert for this search

    Quality Engineer Ii • Lake Zurich, IL, US