Analytical Laboratory Manager – Medical Devices

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: 00/ 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

Bachelors 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 Viswet chemistry
Solid understanding of FDA QSR ISO 13485 and medical device quality systems

Preferred Qualifications

Masters 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.