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Quality Assurance Engineer

2 months ago

Mundelein, Illinois, United States Michael Page Full time
Company Overview

Our client is a reputable manufacturer in the medical device sector, recognized for its commitment to innovation and ongoing enhancement of its product offerings. With a robust presence across multiple locations and a dedicated workforce, they are poised for continued growth and development.

Position Summary

We are seeking a Quality Assurance Engineer to become an integral part of the Quality team. This role will involve direct communication with clients, conducting root cause analyses, and spearheading initiatives on the production floor to enhance operational efficiency.

Key Responsibilities
  • Facilitate regulatory inspections, audits, and inquiries related to product design and manufacturing quality control.
  • Implement and lead various methodologies aimed at product and process enhancement.
  • Evaluate the accuracy and sufficiency of modifications to Bills of Materials (BOMs), Assembly Procedures, Drawings, Component Specifications, FMEAs, and Control Plans.
  • Oversee the completion and upkeep of risk assessments.
  • Generate and finalize protocols and reports for validating testing methods.
  • Collaborate with Manufacturing Engineers to assess processes for both new and existing products, coordinating process validations and capability studies.
  • Develop and document inspection techniques and procedures to ensure product compliance with design specifications, including Incoming, In-Process, and Final Inspection procedures.
  • Ensure that the handling of non-conforming materials adheres to all regulatory standards and that corrective actions are effective in preventing recurrence.
Additional Duties
  • Lead plant Corrective and Preventive Action (CAPA) initiatives, analyzing data and trends related to complaints, supplier quality, non-conforming materials, training effectiveness, and root cause analysis.
  • Engage with suppliers, management, engineers, and manufacturing personnel to resolve quality issues, leading efforts in capability studies and the application of statistical quality control methods.
  • Coordinate and oversee the development of Quality Plans, including inspection, testing, and gauge requirements for new product launches.
  • Provide support to fellow quality engineers as needed.
  • Perform other related functions as required.
Qualifications
  • Bachelor's Degree in Engineering or a related field; a Master's Degree is preferred.
  • A minimum of 4 years of experience in a manufacturing setting, particularly in metalworking or medical device production.
  • Strong background in IQ/OQ/PQ Validations.
  • Experience in Project Management and Lean Manufacturing principles.
  • Proficient in statistical tools and the application of Design of Experiments (DOE) for developing recommendations.
  • Excellent communication and interpersonal abilities.
  • Familiarity with ISO 9001:2015, ISO 13485:2015, 21 CFR, and cGMP regulations.
Compensation and Benefits
  • Competitive salary range based on experience and qualifications.
  • Comprehensive benefits package, including medical, dental, and vision coverage.
  • Health Savings Account and Flexible Spending Accounts.
  • Life and AD&D insurance.
  • Short-term disability coverage.
  • Generous paid time off policy.
  • 401(k) plan with company matching.
Additional Perks
  • Pet insurance options.
  • Tuition reimbursement programs.