Senior QMS Specialist - Medical Device

Chicago, Illinois Permanent USD100,000 - USD120,000 per year
  • Innovation & Impact on Healthcare
  • Professional Growth and Learning Opportunities

About Our Client

One of my clients' strengths lies in its dedication to quality, with a focus on adhering to stringent regulatory standards such as ISO 13485 and FDA requirements. The company fosters a dynamic work environment that encourages continuous learning and professional growth, making it an attractive destination for individuals passionate about making a positive impact on healthcare. The collaborative culture at my clients facility, coupled with effective communication channels, ensures that employees work seamlessly across cross-functional teams.

Job Description

  • Ensure Compliance: Oversee and ensure compliance with relevant medical device regulations, including ISO 13485 and FDA standards, to uphold the highest quality standards in organ preservation and transplantation technologies.
  • Quality Management: Implement and maintain robust quality management systems to monitor and control processes throughout the product life cycle, contributing to the overall quality assurance framework.
  • Risk Management: Utilize effective risk management methodologies to identify, assess, and mitigate potential quality risks associated with my clients' products.
  • Documentation Control: Manage and maintain accurate and up-to-date documentation related to quality processes, ensuring accessibility and adherence to regulatory requirements.
  • Product Testing and Validation: Plan, coordinate, and execute product testing and validation processes to ensure the reliability and performance of my clients' medical technologies.
  • Root Cause Analysis: Conduct thorough investigations into quality issues, employing root cause analysis methodologies to identify the underlying factors and implement corrective and preventive actions.
  • Cross-Functional Collaboration: Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to address quality-related challenges and foster a culture of continuous improvement.
  • Audits and Inspections: Prepare for and participate in internal and external audits, inspections, and assessments to verify compliance with regulatory standards and identify areas for improvement.
  • Supplier Quality Management: Collaborate with suppliers to ensure the quality of incoming components and materials, implementing effective supplier quality management processes.
  • Training and Development: Provide training and guidance to internal teams on quality-related processes, standards, and procedures, contributing to the ongoing professional development and awareness of quality requirements within the organization.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Bachelor's Degree in Engineering
  • Knowledge of ISO 13485, FDA experience
  • Exposure to front room audits
  • Experience LEADING internal audits
  • Proven experience with Root Cause and CAPAs
  • Supplier audit experience - we have suppliers overseas but also in the US
  • Experience helping developing processes and QMS

What's on Offer

  • Salary between $100,000 to $120,000
  • Stock Options
  • Unlimited PTO
  • Insurance, Medical and Vision
  • 401K match
Ben Aldrich
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Job summary

Engineering & Manufacturing
Sub Sector
Quality, Technical
Industrial / Manufacturing
Contract Type
Consultant name
Ben Aldrich
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