Part Time Root Cause Analysis Jobs in Chicago, IL

MatchPoint Solutions is a fast-growing, young, energetic global IT-Engineering services company with clients across the US. We provide technology solutions to various clients like Uber, Robinhood, Netflix, Airbnb, Google, Sephora, and more! More recently, we have expanded to working internationally in Canada, China, Ireland, UK, Brazil, and India. Through our culture of innovation, we inspire, build, and deliver business results, from idea to outcome. We keep our clients on the cutting edge of the latest technologies and provide solutions by using industry-specific best practices and expertise.
We are excited to be continuously expanding our team. If you are interested in this position, please send over your updated resume. We look forward to hearing from you!
Job Title: Analytical Laboratory Manager - Medical Devices
Location: (Remote / Hybrid / On-site - City, Country) Chicago, Illinois
Employment Type: (Full-time / Part-time / Contract) Contract/FTE
Pay Range: 100000-120000/+ Benefits
Reports to (optional) : Director, Quality / Senior Quality Manager
Position Summary
The Analytical Laboratory Manager is responsible for leading and maintaining a compliant analytical
laboratory that supports medical device manufacturing, product release, validation, and laboratory
investigations. This role ensures laboratory operations meet FDA Quality Management System
Regulation (21 CFR Part 820), ISO 13485:2016, and applicable international regulatory requirements.
The manager provides technical and people leadership, ensures data integrity, and drives continuous
improvement while maintaining inspection readiness at all times.
Key Responsibilities
Laboratory Leadership & Operations:
• Lead day-to-day analytical laboratory operations supporting incoming inspection, in-process
controls, final product release, validation, and complaint investigations
• Ensure analytical testing is accurate, timely, and aligned with product and regulatory
requirements
• Review and approve analytical test results, reports, and data packages prior to product
disposition
• Establish priorities and resource allocation to support production and quality needs
Regulatory Compliance & Quality Systems
• Ensure laboratory compliance with FDA QMSR (21 CFR 820), ISO 13485, and applicable ISO
testing standards
• Author, review, approve, and maintain laboratory SOPs, work instructions, test methods,
and validation protocols
• Maintain inspection readiness and support FDA, notified body, customer, and internal audits
• Lead or support laboratory investigations including OOS/OOT, nonconformances, deviations,
CAPAs, and change controls
• Ensure ALCOA+ data integrity principles are implemented and sustained within the lab
Analytical Methods & Equipment
• Oversee development, validation, verification, and lifecycle mngmt of analytical methods
• Ensure laboratory equipment is properly qualified, calibrated, maintained, and documented
• Manage equipment obsolescence, upgrades, and new technology introduction
• Evaluate and select external test laboratories when internal testing is not available
People Management & Development
• Directly manage laboratory analysts, technicians, and/or supervisors
QFocus Lab Manager - Job Description
• Ensure personnel training, qualification, and competency assessments are completed and
maintained
• Mentor staff on technical skills, GMP compliance, documentation, and root cause analysis
• Promote a culture of accountability, quality, and continuous improvement
Safety & Environmental Compliance
• Ensure laboratory compliance with EHS requirements, chemical hygiene plans, and waste
disposal regulations
• Promote safe laboratory practices and respond to safety incidents or near misses
Continuous Improvement & Cross-Functional Support
• Drive continuous improvement initiatives to enhance lab efficiency, compliance, and cost
effectiveness
• Partner with Manufacturing, Engineering, Supplier Quality, R&D, and Regulatory Affairs to
resolve quality and technical issues
• Support process validation, design verification/validation (DV/PV), and technology transfers
Required Qualifications
• Bachelor's degree in Chemistry, Analytical Chemistry, Materials Science, Engineering etc.
• Minimum 5-7 years of analytical laboratory experience in a regulated medical device or life
sciences environment
• At least 2 years of people leadership or technical leadership experience
• Strong working knowledge of analytical techniques- HPLC, GC, FTIR, UV-Vis,wet chemistry
• Solid understanding of FDA QSR, ISO 13485, and medical device quality systems
Preferred Qualifications
• Master's degree in a scientific or engineering discipline
• Direct experience supporting FDA or notified body inspections
• Experience with Laboratory Information Management Systems (LIMS)
• Six Sigma, Lean, or formal root cause analysis training
Key Competencies
• Strong leadership and coaching skills
• Experience with analytical instrumentation and assays
• High attention to detail and data integrity
• Excellent written and verbal communication
• Proven problem-solving and decision-making ability
• Ability to manage multiple priorities in a fast-paced manufacturing environment
Working Conditions
• Occasional off-shift or weekend support may be required for investigations, audits, or
validation activities
• Combination of laboratory and office work environment
MatchPoint Solutions provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.