Quality Manager

We are seeking an experienced and hands-on Quality Manager to lead and develop a dedicated quality team in a regulated medical device manufacturing environment. This is a clean-room facility that performs its own in-house sterilization processes. This role offers the opportunity to make an immediate impact—guiding a capable but developing team to see the bigger picture, elevate standards, and ensure the highest level of compliance with stringent industry and regulatory requirements. Key ResponsibilitiesLead, mentor, and develop a team (including Quality Technicians, Chemists, Microbiologists, Document Control, and Customer Complaint staff).Foster a culture of quality awareness, continuous improvement, and accountability.Ensure compliance with applicable regulations and standards, including:ISO 13485 – Quality Management Systems for Medical DevicesISO 17665 – Sterilization of Health Care Products – Moist HeatISO 11135 – Sterilization of Health Care Products – Ethylene OxideISO 11137 – Sterilization of Health Care Products – RadiationFDA 21 CFR requirementsServe as the facility’s designated representative for the drug program (U.S. citizenship required for this responsibility).Oversee and support sterilization procedures and validation activities.Lead or participate in internal and external audits, including FDA inspections and third-party audits.Manage and improve QA/QC processes, document control systems, and customer complaint handling.Partner with production and engineering teams to resolve quality issues and drive preventive measures.Maintain readiness for audits and inspections at all times.Travel as needed to support international operations (~20%, primarily to Mexico).QualificationsRequired:Bachelor’s degree in a relevant scientific, engineering, or quality discipline (or equivalent experience).10 years of progressive quality experience in medical device and/or pharmaceutical manufacturing.Proven success as a people manager, with the ability to bring out the best in diverse, technical teams.Strong working knowledge of FDA regulations and ISO standards relevant to medical devices and sterilization.Hands-on leadership style—comfortable being present on the manufacturing floor, not just in an office.Experience in QA, QC, and Quality Management systems.Demonstrated success leading audits.U.S. citizenship (due to regulatory representative requirements).  Preferred/Nice-to-Have:Spanish language skills.Experience in clean-room manufacturing environments.  Why This Role?This is an opportunity to step into a leadership position where your expertise in regulated manufacturing and team leadership will directly shape product quality, compliance, and operational success. Joining an extremely collaborative environment with a great work culture in a fast paced and fun environment.Benefits:401(K) MatchDental InsuranceHealth InsuranceLife InsurancePaid Time offVision Insurance  Company DescriptionAt Quanta we dedicate all of our attention to the Human Capital. We’re a recruiting and HR consulting firm specializing in connecting employers nationwide with the most qualified talent across a variety of industries and business functions.Our primary focus is on North American and Italian clients and we provide a complete suite of HR solutions, including Executive & Management Search, HR Consulting, and Flexible Staffing.We are a team of people with international backgrounds, different expertise and seniority. We were brought together by our common passion in the key element that makes any organization possible: the human element.We are passionate about what we do and enjoy and have fun doing it. Our approach is very personable and we obsess over one constant: uncompromising quality.

Salary : $130,000 - $150,000