Quality Engineer II

BioLab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to raise the standard of caring. Since its founding, BioLab Holdings has experienced explosive growth and is actively developing new technologies to innovate, improve customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our companys mission. Job Overview We are seeking a detail?oriented and hands?on Quality Engineer II to join our Quality Team. This role will focus on ensuring compliance with regulatory standards and supporting continuous improvement initiatives. You will be instrumental in enhancing our quality systems, improving processes, and supporting new product launches and regulatory submissions. The ideal candidate will ensure compliance with regulatory standards, lead continuous improvement initiatives, and collaborate cross?functionally to maintain the highest quality standards throughout the product lifecycle. Essential Functions Quality System Improvement Develop and implement strategies to enhance quality systems, ensuring compliance with GMP, FDA 21 CFR 1271, AATB, ISO 13485, FDA 21 CFR 820, and EU MDR regulations Review and optimize manufacturing processes to improve efficiency, product quality, and regulatory compliance Support change management processes, including impact assessments for process, material, or equipment changes Process Validation Design, execute, and document process validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Ensure process validation protocols meet regulatory requirements and industry standards for medical devices and HCTP Analyze validation data to confirm process capability and consistency, supporting manufacturing scalability Nonconformance & CAPA Management Lead investigations for nonconformances, CAPAs, and customer complaints, performing root cause analysis and implementing corrective actions Disposition nonconforming materials and collaborate with suppliers on corrective actions (SCARs) Analyze post?market data to drive design or process improvements for new and existing products Risk Management and Continuous Improvements Conduct risk analysis for nonconformances, continuous improvement efforts, and validation activities to maintain regulatory compliance and effective product management Review and refine test methods, inspection procedures, and process controls to ensure compliance and optimize manufacturing workflows Support internal and external audits, including preparation and response coordination Perform data analysis to identify trends, quality issues, and opportunities for manufacturing improvements Drive continuous improvement of quality practices across the organization Documentation & Training Provide training and guidance in manufacturing on quality?related best practices, procedures, and compliance standards * This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned. Qualifications Education: Minimum Bachelor's degree in Engineering required Experience: Minimum of 2-4 years of experience in the tissue banking, pharmaceutical or medical device industries Demonstrated experience in process validation, risk management, quality system improvements, and supporting new product launches, and regulatory submissions Familiarity with compliance in tissue, medical, or pharmaceutical manufacturing Experience with Manufacturing Execution Systems (MES) is preferred Six Sigma Yellow or Green Belt certification is preferred Strong knowledge of GMP, ISO 13485, FDA 21 CFR 820, EU MDR, and risk management standards (e.g., ISO 14971) Excellent communication skills with the ability to work collaboratively in a cross?functional environment Detail?oriented with the ability to handle complex issues and drive solutions effectively Strong analytical skills, with proficiency in data analysis tools (e.g., Minitab, Excel) for process and quality improvements What We Offer Looking for a company to work at can be a daunting task, but we believe that we stand out from the rest. Our company offers a positive and inclusive work environment, opportunities for growth and development, and a commitment to work?life balance. Join us and become part of a team that values your contributions and invests in your success. Total Rewards Package Health, Dental, and Vision Insurance Retirement Plans Tuition Reimbursement Generous Paid Time Off Employee Assistance Program No premium payments BioLab Holdings is an Equal Opportunity employer and does not discriminate based on race, ancestry, color, religion, sex, age, marital status, sexual orientation, national origin, medical condition, disability, veteran status, gender identity, or any other basis protected by law. #J-18808-Ljbffr