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.
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