Quality Assurance Manager

Productiv is a high-performance third‑party logistics (3PL) company specializing in kitting, assembly, and omnichannel fulfillment for some of the biggest consumer brands in the country. Nine of every ten of our clients are billion‑dollar brands. We move 30 million+ kits a year. We run 14 operations nationwide, with our Dallas–Fort Worth campus serving as one of our flagship hubs — and we're growing fast. Learn more at . We are seeking a Bilingual (English/Spanish) Quality Assurance Manager at our Charlotte, NC hub to lead compliance, quality systems, and continuous improvement across our high‑volume, fast‑paced operations. This role offers direct impact on nationally recognized brands, hands‑on leadership in a growing organization, and the opportunity to build scalable quality programs from the ground up. Reports to VP of Engineering Regulatory Compliance & Certifications Ensure compliance of Class I medical device production with Productiv procedures and global regulatory requirements including the U.S. FDA, EU regulations, ICH, Health Canada, and other applicable standards. Maintain company registrations and ensure compliance with TTB, DECCS/DDTC, and ATF, as applicable. Support certification and compliance frameworks including NSFI, ISO standards, GFSI‑recognized schemes, BRCGS, SQF, and FSSC 22000. Quality Management System (QMS) & Documentation Develop, implement, and maintain SOPs, specifications, inspection criteria, and quality control procedures. Lead key quality system activities including batch release, SOP approval, and change control. Review cGMP‑related documentation to ensure accuracy, completeness, and compliance with internal procedures and regulatory requirements. Establish and maintain quality standards and ongoing quality objectives aligned with operational and customer requirements. Audits, Compliance & Investigations Plan and perform internal and external audits to ensure compliance with regulatory and certification standards. Lead investigations into product nonconformance, device malfunctions, and customer complaints; ensure proper evaluation, reporting, and closure. Direct and conduct data integrity and compliance investigations, including root cause analysis and CAPA implementation. Production Quality Oversight Oversee inspection and testing activities across the production cycle to ensure product quality and process control. Supervise quality personnel to maintain high productivity and quality standards. Collaborate with production and cross‑functional teams to align quality requirements with operational execution. Interface with suppliers to ensure quality of purchased materials and components. Analytics, Reporting & Technical Support Analyze statistical data and product specifications to define quality standards and reliability expectations. Provide technical and statistical expertise to support decision‑making and process improvements. Apply Total Quality Management (TQM) tools and structured problem‑solving methodologies to drive performance. Customer Quality & Continuous Improvement Ensure a high level of internal and external customer service related to quality performance. Lead continuous improvement initiatives and participate in cross‑functional CI teams. Design, develop, and implement quality training programs to reinforce compliance and operational excellence. Communicate quality standards and expectations clearly to all levels of the organization. Qualifications Must be Bilingual (English/Spanish) Minimum 5+ Years of experience in a quality management position Minimum of 2+ years in a Managerial QA position or equivalent Must be able to communicate clearly (Spanish and English) Excel (Advanced) Power BI Demonstrated AI usage Preferred experience with inspection and compliance platforms such as SafetyChain, FoodLogiQ/Trustwell, CAT Squared, or similar systems. ITAR Compliance Requirement Applicants must be a "U.S. Person" as defined by the International Traffic in Arms Regulations (ITAR) (22 C.F.R. § 120.62) to satisfy export control requirements for this position. This includes U.S. citizens, permanent residents (Green Card holders), temporary residents granted authorization, asylees, or refugees. Schedule Monday‑Friday 8a-5p (or a variation of) Competitive salary: $60,000 – $70,000 per year , based on experience Health, dental, and vision insurance 401(k) with company match Paid time off (PTO) and holidays Real career growth — we promote from within and we mean it Direct access to decision-makers — no corporate ladder to climb just to get an answer A team that solves problems together at a company that's actually growing We will pay for ISO and HACCP certifications or similar Productiv Inc. Productiv Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, or disability. Because this position involves access to ITAR‑regulated technology, all offers of employment are contingent upon candidates verifying "U.S. Person" status or the company securing a valid federal export license. 13327 Carowinds Blvd, Suite A, Charlotte, NC 28273 #J-18808-Ljbffr