Instrumentation Laboratory Company

Quality Engineer - Systems Assurance

Instrumentation Laboratory Company • $80K — $110K *
Waukesha, WI 53188In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, Quality, or related fields; Master's preferred
  • 7+ years in medical device, pharmaceutical, or biotechnology sectors focusing on CAPA and complaint management
  • Deep understanding of regulatory standards including FDA 21 CFR 820, ISO 13485, and EU MDR
  • Expertise in CAPA investigations and risk management (ISO 14971)
  • Experience with electronic Quality Management Systems (eQMS) like TrackWise or MasterControl
  • Strong analytical and leadership capabilities
  • Excellent communication skills, both verbal and written

Responsibilities

  • Oversee the complete CAPA process, ensuring timely action and resolution
  • Review root cause analyses to identify systemic issues through techniques like 5 Whys and FMEA
  • Conduct CAPA effectiveness checks in accordance with regulatory requirements
  • Manage customer complaint investigations and coordinate cross-functional teams for resolution
  • Ensure compliance with regulatory reporting requirements for incidents
  • Serve as Subject Matter Expert during regulatory audits and inspections
  • Support other Quality Management Systems, including supplier management and risk management

Benefits

  • Continual professional development and training opportunities
  • Inclusive and supportive workplace environment
  • Limited travel requirements (5% or less annually)
  • Engagement with various departments for collaboration and support
  • Opportunity to drive operational excellence through improvement initiatives.
Full Job Description
Overview

The Quality Engineer - CAPA and Customer Complaint is responsible for overseeing corrective and preventive actions, managing customer complaints, and ensuring compliance with quality and regulatory standards. This role ensures that US Transplant Technololgy CAPA and complaint processes comply with FDA, ISO 13485, IVDR, and other global regulatory requirements while driving operational excellence.

Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)

Responsibilities

Key Accountabilities

CAPA Management:
  • Oversee the end-to-end CAPA process, ensuring timely identification, investigation, and closure of corrective and preventive actions
  • Supports the review of root cause analyses (e.g., 5 Whys, Fishbone Diagrams, FMEA) to ensure proper and thorough investigations have been conducted and identify systemic issues
  • Ensure CAPA effectiveness checks are conducted and documented per regulatory requirements
  • Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
  • Drive continuous improvement initiatives to optimize efficiency and compliance

Complaint Handling & Investigation:
  • Manage the customer complaint process; investigation, documentation and resolution
  • Coordinate cross-functional teams (Technical Support, Quality, Regulatory, and Manufacturing) to investigate complaints and implement corrective actions
  • Ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events

Regulatory Compliance & Audits:
  • Ensure CAPA and complaint processes align with FDA, ISO 13485, EU IVDR, and other global regulations
  • Serve as Subject Matter Expert (SME) during regulatory audits and inspections
  • Maintain compliant and CAPA metrics for Management Review and continuous improvement initiatives
  • Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
  • Drive continuous improvement initiatives to optimize efficiency and compliance
  • Support other Quality Management Systems as required; applicable subsystems include, but are not limited to, supplier management, risk management and change control
  • Other duties as assignedeasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships
  • Daily interaction with all departments domestic and international to support CAPA training and CAPA Closure.
  • Interaction with Manufacturing Technical Support team in support of product investigations.
  • Interaction with Research and Development to support product complaints and product improvements.
  • Interaction with Quality Assurance for quality and regulatory compliance.
  • Interaction with Customer Technical Support team in support of customer complaint investigation.


Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)

Qualifications

Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)

Minimum Knowledge & Experience required for the position:
  • Bachelor's degree in Engineering, Life Sciences, Quality, and/or related fields; Master's degree preferred
  • Minimum 7 years of experience in medical device, pharamaceutical, or biotechnology industries with a focus on CAPA and complaint handling. (Preferably direct experience with IVD's for HLA screening, and ELISA products)
  • Strong understanding of FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations
  • Expertise in CAPA investigations, root cause analysis (RCA), and risk management (ISO 14971)
  • Experience with electronic QMS (eQMS) systems (e.g.,TrackWise, MasterControl, SAP)
  • Strong analytical, communication, and leadership skills
  • Excellent verbal and written communication skills
  • Exhibits a disciplined approach to work ensuring thoroughness, consistency, validation, and accuracy in all tasks and work product
  • Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement Skills & Capabilities:
  • Effective communication
  • Strong leadership
  • Proactive problem-solving
  • Stategic thinking
  • Organizational skills and time management
  • Coaching skills for improvement and problem solving
  • Continous learning and development mindset
  • Conflict resolution
  • Foster a positive and inclusive work environmentTravel requirements:
  • 5% or less annually

About Instrumentation Laboratory Company

Instrumentation Laboratory Company (IL) is a global leader in the development, manufacturing and distribution of diagnostic solutions for Acute Care Diagnostics, with a focus on Critical Care and Hemostasis testing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. IL develops, manufactures and distributes diagnostic solutions including: critical care systems, hemostasis systems and information management systems. IL's products are used in hospitals around the world, including large hospital systems, independent hospitals and clinics, and reference laboratories. IL is headquartered in Bedford, Massachusetts, and has operations in Europe, the Middle East, Africa, Asia-Pacific, and Latin America.
Learn more about Instrumentation Laboratory Company
Size
1,000 employees
Industry
Healthcare
Net Income
$50 million
5 Year Trend
+5%
Revenue
$500 million
* Ladders Estimates

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