QA Manager

Description

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 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.

Requirements

• 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

• 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)

Pay/Benefits

• 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

Perks

We will pay for ISO and HACCP certifications or similar