LSL Healthcare ยท 2 months ago
Senior Quality Assurance Quality Control Engineer
Niles, IL
Full-time
Onsite
Senior Level
$71K/yr - $85K/yr
6+ years expLSL Healthcare is a leading national supplier recognized as a trusted partner in healthcare supply chains. They are seeking a highly experienced Senior Quality Assurance/Quality Control Engineer to lead and support key quality and compliance initiatives throughout the development and commercialization of medical products.
Health CareManufacturingMedical DeviceQuality Assurance
Responsibilities
Lead quality assurance efforts throughout the design, development, and commercialization phases of medical devices and combination products
Review and maintain Design History Files (DHF's) to ensure completeness, accuracy and compliance with FDA, ISO 13485, and company procedures. Manage and contribute to the Design History File (DHF) documentation, including development, review, approval, and maintenance for regulatory filings and design transfer
Lead and perform risk management activities using ISO 14971 standards, focusing on product safety, defining critical quality attributes, and assessing residual risks
Ensure compliance with applicable medical device regulations (e.g., 21CFR820, ISO 13485, QMSR, MDSAP) and internal quality system requirements
Collaborate extensively with cross-functional teams on quality systems, design requirements, issue resolution, and problem-solving efforts
Support preparations for, and participate in, regulatory agency inspections and internal/external audits
Develop, revise, and review policies, procedures, and technical documentation to maintain and effective quality systems
Manage on-market design changes, identify gaps/improvement opportunities, and lead investigations for CAPAs and NCRs (Non-Conformance Reports)
Support the creation of regulatory submission documentation and evaluate proposed manufacturing changes for regulatory filing strategies
Lead accelerated aging (ASTM F1980) and real-time aging studies for shelf-life determination of packaged products
Design, formulate, and execute sterilization validation studies (IQ, OQ, PQ)
Establish routine monitoring programs for sterilization and plan and execute requalification activities
Qualification
Required
Expertise in sterilization, auditing, remediation, and cross-functional collaboration
Lead quality assurance efforts throughout the design, development, and commercialization phases of medical devices and combination products
Review and maintain Design History Files (DHF's) to ensure completeness, accuracy and compliance with FDA, ISO 13485, and company procedures
Manage and contribute to the Design History File (DHF) documentation, including development, review, approval, and maintenance for regulatory filings and design transfer
Lead and perform risk management activities using ISO 14971 standards, focusing on product safety, defining critical quality attributes, and assessing residual risks
Ensure compliance with applicable medical device regulations (e.g., 21CFR820, ISO 13485, QMSR, MDSAP) and internal quality system requirements
Collaborate extensively with cross-functional teams on quality systems, design requirements, issue resolution, and problem-solving efforts
Support preparations for, and participate in, regulatory agency inspections and internal/external audits
Develop, revise, and review policies, procedures, and technical documentation to maintain effective quality systems
Manage on-market design changes, identify gaps/improvement opportunities, and lead investigations for CAPAs and NCRs (Non-Conformance Reports)
Support the creation of regulatory submission documentation and evaluate proposed manufacturing changes for regulatory filing strategies
Lead accelerated aging (ASTM F1980) and real-time aging studies for shelf-life determination of packaged products
Design, formulate, and execute sterilization validation studies (IQ, OQ, PQ)
Establish routine monitoring programs for sterilization and plan and execute requalification activities
Preferred
Remediation experience is desired
Regulatory Affairs experience is desired
Project management skills and ability to manage multiple tasks simultaneously
Experience with documentation software (e.g., eQMS, PLM, SharePoint, Power BI)
Experience working with Notified Bodies or Regulatory Authorities
Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)
Knowledge of sterile barrier systems (SBS) and protective packaging
Knowledge of sterilization principles, cycles, and parameters
Experience with Bioburden Monitoring (ISO 11737)
Experience with BI testing and sterility testing (ISO 11737)
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
Minimum 6 years of experience in quality assurance/quality control roles within regulated industries, including medical device, healthcare or combination product sectors
Strong understanding and experience in product development, design controls (21 CFR 820.30), and risk management
Demonstrated ability to work effectively in teams, independently within a cross-functional framework, and adapt to a matrix organization
Excellent written and oral communication skills, including technical writing, and strong interpersonal, stakeholder management, and negotiation skills
Proven problem-solving mindset and the ability to resolve complex issues
High degree of creative thinking, resourcefulness, and networking abilities
Flexibility to adapt to a fast-paced environment
Benefits
Health insurance
Dental
Vision
Life
Short- term and long-term disability
AD&D insurance
401(k) savings plan with employer match
Paid time off
Holiday pay
Professional development opportunities
Company
LSL Healthcare
LSL Healthcare is a manufacturer of quality medical devices and disposable kits.
51-200 employees
H1B Sponsorship
LSL Healthcare has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
5th Century Partners
2022-12-15Private Equity
2022-12-15Acquired
Recent News
5th Century Partners
2025-03-26
Company data provided by crunchbase