Quality Assurance Lead

As a Quality Assurance Lead, you will spearhead our quality initiatives by overseeing inspection personnel and ensuring rigorous adherence to regulatory standards. You will play a pivotal role in optimizing production quality processes and serving as a key technical resource for the department. About the Role As a Quality Assurance Lead, you will spearhead our quality initiatives by overseeing inspection personnel and ensuring rigorous adherence to regulatory standards. You will play a pivotal role in optimizing production quality processes and serving as a key technical resource for the department. Responsibilities Direct and mentor quality inspection staff to ensure consistent performance and professional development. Enforce ISO 13485 compliance across all production and laboratory activities to maintain high-quality output. Streamline quality procedures and documentation to improve operational efficiency and audit readiness. Coordinate with cross-functional teams to resolve complex quality issues and align on production priorities. Manage shift staffing and training schedules to ensure seamless coverage and skill competency. Utilize SPC software to monitor process stability and drive continuous improvement initiatives. Act as a primary point of contact for quality-related inquiries and provide leadership support to the QA management team. Required Skills High school diploma or equivalent required; Associate or Bachelor degree preferred. Minimum of 2 years of experience supervising a QA lab within an ISO 13485 regulated environment. Demonstrated proficiency in MS Office Suite (Excel, Word, PowerPoint, Outlook). Strong technical aptitude with Statistical Process Control (SPC) software. Exceptional organizational and communication skills to facilitate knowledge sharing. Ability to pass pre-employment reading and measurement assessments. Preferred Skills Prior experience within the flexible packaging industry. Hands‑on experience with ERP systems for data management. Proven track record of managing quality workflows in a medical device or pharmaceutical setting. Our Story Founded in Montana, Mach10 Solutions has rapidly expanded to provide premium fabrication and engineering services across the United States. Our journey began with a simple mission: deliver precision engineering solutions at unprecedented speeds. Today, we leverage cutting‑edge technology and exceptional talent to provide manufacturing services that consistently exceed expectations. With a focus on quality, speed and innovation, we’ve become the trusted partner for companies seeking competitive advantages through superior fabrication and design. At Mach10, we don’t just build components – we forge lasting partnerships through reliability, expertise, and our commitment to pushing the boundaries of what’s possible. Our Services Precision Fabrication State‑of‑the‑art manufacturing delivering tight‑tolerance components with uncompromising accuracy. Design & Drafting Comprehensive CAD modeling, documentation and DFM optimization to ensure flawless execution. Field Services Nationwide on‑site technical support, installation and maintenance from highly trained experts. Quality Assurance Rigorous inspection protocols guarantee every component meets or exceeds industry standards. Project Management End‑to‑end project coordination with clear communication and on‑time delivery. Rapid Prototyping Accelerated development cycles turn concepts into functional prototypes at record speed. Why Choose Mach10 17+ States Served 64+ Projects Completed 98.2% Quality Rating 24/7 Technical Support Recent Projects Automotive Prototype Rapid‑turn aluminum prototype trimmed production timeline by 6weeks. Fully integrated robotic welding cell installed and commissioned on‑site. #J-18808-Ljbffr Mach10 Solutions