Senior Quality Assurance Quality Control Engineer

Senior Quality Assurance Quality Control Engineer

LSL Healthcare is a leading national supplier and a certified Minority Business Enterprise (MBE), recognized as a trusted partner in healthcare supply chains. We specialize in customizing medical and surgical kits, procedure trays, and disposable medical equipment. Committed to quality, value, and exceptional customer service, we provide tailored solutions to meet the unique needs of healthcare facilities nationwide.

Role Description

We are seeking a highly experienced and detail-oriented Senior Quality Assurance/Quality Control (QA/QC) Engineer to lead and support key quality and compliance initiatives. This position provides independent quality assurance support throughout the development and commercialization of medical products including combination products, ensuring adherence to regulatory requirements and internal quality standards. The ideal candidate will have expertise in sterilization, auditing, remediation, and cross-functional collaboration.

This role reports directly to the Director of Quality & Regulatory.

Key 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., 21
  
  CFR
  820, 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.

Preferred Qualifications

• Remediation 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.

Preferred Experience

• 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…