Senior Quality Assurance Engineer

Company Description LSL Healthcare is a premier national supplier and a certified Minority Business Enterprise (MBE), recognized as a trusted partner in healthcare supply chains. Our specialization lies in customizing medical and surgical kits, procedure trays, and disposable medical equipment. We are dedicated to quality, value, and exceptional customer service, providing tailored solutions to meet the unique needs of healthcare facilities across the nation. Role Description We are in search of a highly skilled and detail-oriented Senior Quality Assurance Engineer to lead and support critical quality and compliance initiatives. This role provides independent quality assurance throughout the development and commercialization of medical products, including combination products, ensuring compliance with regulatory requirements and internal quality standards. The ideal candidate will possess expertise in sterilization, auditing, remediation, and cross-functional collaboration. This position reports directly to the Director of Quality & Regulatory. Key Responsibilities Lead quality assurance efforts during the design, development, and commercialization phases of medical devices and combination products. Review and maintain Design History Files (DHF) to ensure completeness, accuracy, and compliance with FDA standards, ISO 13485, and company procedures. Conduct risk management activities following ISO 14971 standards, focusing on product safety and residual risk assessment. Ensure regulatory compliance with applicable medical device regulations (e.g., 21CFR820, ISO 13485) and internal quality system requirements. Collaborate with cross-functional teams on quality systems, design requirements, and problem-solving initiatives. Prepare for and participate in regulatory agency inspections as well as internal and external audits. Develop, revise, and review policies, procedures, and technical documentation to maintain effective quality systems. Manage design changes, identify improvement opportunities, and lead investigations for CAPAs and Non-Conformance Reports (NCR). Assist in creating regulatory submission documentation and evaluate manufacturing changes for regulatory strategy. Conduct accelerated aging and real-time aging studies for determining shelf-life of packaged products. Design and execute sterilization validation studies (IQ, OQ, PQ). Establish routine monitoring programs for sterilization and execute requalification activities. Preferred Qualifications Experience with remediation and regulatory affairs is preferred. Strong project management skills with the ability to juggle multiple tasks effectively. Familiarity with documentation software (e.g., eQMS, PLM, SharePoint, Power BI). Experience working with Notified Bodies or Regulatory Authorities. Certification as a Quality Auditor (CQA) or Quality Engineer (CQE) is valued. Knowledge of sterile barrier systems and protective packaging. Understanding sterilization principles, cycles, and parameters. Experience in Bioburden Monitoring and sterility testing. Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. Preferred Experience At least 6 years of experience in quality assurance/quality control within regulated industries, particularly in medical devices or healthcare. Strong grasp of product development, design controls, and risk management. A demonstrated ability to collaborate effectively within teams and adapt to a matrix organization. Excellent written and oral communication skills, technical writing proficiency, and strong interpersonal skills. Proven problem-solving skills and the capacity to tackle complex issues creatively. Ability to thrive in a dynamic and fast-paced environment. Compensation & Benefits: The anticipated salary range for this position is $70,873.42 - $85,352.94 annually. Actual pay may vary based on location, education, relevant experience, and skills. This role is also eligible for bonuses and performance incentives. LSL Healthcare provides a competitive salary along with a comprehensive benefits package, including health, dental, and vision insurance, life insurance, short-term and long-term disability coverage, a 401(k) savings plan with an employer match, paid time off, holiday pay, and professional development opportunities. LSL Healthcare is an equal opportunity employer committed to diversity and inclusion, and we welcome applications from all individuals regardless of race, color, religion, age, sex, sexual orientation, gender identity, national origin, veteran or disability status, or other statuses protected by law.