At SATO America, LLC, our mission is to create new value for our customers through products and services of superior quality and to contribute toward a better and more sustainable world.
For more than 80 years, SATO has fostered a culture of professionalism and customer-centric innovation with an unchanging mission of creating value for customers that, in turn, contributes to a more sustainable world.
This is a full-time, permanent position at SATO America.
Job title: Quality Specialist
Onsite position
Job Location: Charlotte, NC, 28273, United States
SUMMARY:
The QA Specialist role is an onsite role based in Charlotte, North Carolina.
In this role as QA Specialist at SATO America, you would be supporting and maintaining the Quality Management System (QMS) in alignment with the company's all certification programs. This role ensures compliance with regulatory requirements, and other guidelines such as cGMP, Underwriters Laboratory (UL), Forest Stewardship Council (FSC) based on business and customer needs, while fostering a strong Quality Culture and Safety Culture across the organization.
You play a key role in non-conformance management, auditing, support for supplier quality oversight, document control, and continuous improvement initiatives. The organization is committed to operational excellence through a robust ISO 9001 Quality Management System and a proactive Environmental, Health & Safety (EHS) program that emphasizes accountability, prevention, and continuous improvement.
TRAVEL REQUIREMENTS:
25-50% or as needed
KEY RESPONSIBILITIES:
Non-Conformance Management
- Manage and document non-conformances, deviations, CAPA's, and quality events in accordance with ISO 9001 QMS requirements.
- Lead investigations to determine root cause and implement corrective and preventive actions (CAPA).
- Track, trend, and analyze non-conformance data to identify systemic issues.
- Ensure timely closure and effectiveness verification of CAPAs.
Regulatory & Compliance
- Ensure compliance with applicable regulatory standards (REACH, RoHS etc.), cGMP, ICH guidelines, and ISO 9001 requirements.
- Support regulatory requests.
- Maintain inspection and audit readiness at all times.
- Support external regulatory inspections (UL, FSC etc.) and customer audits.
- Promote adherence to standardized processes and continuous improvement principles consistent with ISO 9001.
cGMP Compliance Auditor
- Conduct audits to ensure compliance with current Good Manufacturing Practices (cGMP) and ICH guidelines.
- Identify compliance gaps and recommend corrective actions.
- Prepare audit reports and ensure timely follow-up on findings.
Internal Auditor
- Plan and execute internal audits across departments in accordance with ISO 9001 QMS.
- Evaluate effectiveness of quality systems and process controls.
- Support management review and continuous improvement activities.
Supplier Quality Audits (as Needed)
- Conduct supplier qualification and periodic audits as required.
- Collaborate with Procurement and Operations to ensure supplier compliance.
- Attend Supplier QA meetings and provide quality oversight.
Supports Customer Feedback (CF)
- Assist in responding to customer quality inquiries, complaints, and corrective actions.
- Support customer audits and quality-related communications.
- Partner with Customer Feedback (CF) teams to ensure high levels of customer satisfaction and compliance.
Document Control
- Maintain controlled documents in accordance with ISO 9001 QMS standards.
- Create, review, approve, distribute, and archive SOPs, work instructions, and quality records.
- Ensure document traceability and revision control.
- Support electronic document management systems (EDMS).
Quality Training Program Support
- Support implementation and maintenance of the Quality Training Program.
- Provide quality training as needed or requested for employees.
- Maintain accurate training records and competency documentation.
- Assist in development of training materials and facilitate sessions as needed.
Cross-Functional Engagement
- Attend and provide QA input at meetings related to:
- Raw material changes
- Preflight reviews
- Process or change control discussions
- Supplier QA meetings
- Perform quality risk assessments during change management activities.
Problem-Solving & Root Cause Analysis
- Participate in cross-functional problem-solving initiatives.
- Utilize structured methodologies (5 Whys, Fishbone, FMEA, etc.) to determine root cause.
- Drive implementation of sustainable corrective and preventive actions.
- Support continuous improvement projects aligned with ISO 9001 principles.
Inspections
- Perform inspections as needed and complete analytical testing or evaluations of inspections as needed.
Safety (EHS)
- Comply with Environmental, Health & Safety (EHS) policies and procedures.
- Manage and participate in EHS audits, risk assessments, and safety initiatives.
- Report hazards, incidents, and unsafe conditions promptly.
- Support corrective actions related to safety events.
- ESH site champion.
Safety Culture & Quality Culture
- Actively promotes a strong Safety Culture focused on prevention, accountability, and continuous improvement.
- Champion a robust Quality Culture that emphasizes compliance, integrity, data accuracy, and operational excellence.
- Lead by example in following procedures, reporting issues, and driving improvements.
- Encourage open communication and proactive identification of risks affecting product quality or employee safety.
QUALIFICATIONS:
Required:
- H.S Diploma//GED
- 3-5 years' proven experience in Quality Assurance or Regulatory Compliance experience in a manufacturing environment required.
- Internal auditor certified, CIA/CQA.
- Certified training in ISO 9001, ISO 13485, ISO 22000 etc.
- Experience in non-conformance investigations and CAPA management.
- Working knowledge of ISO 9001-certified Quality Management System.
- Writing and Communication Skills (e.g. write technical reports, present data analysis).
- Experience with MS Office including Excel, Power Point and Visio.
- Must be detail-orientated, self-motivated and available for flexible scheduling.
- Ability to travel 25-50% or as needed.
Preferred:
- A college degree or equivalent combination of education and work experience in quality assurance, related Industrial, scientific, or business field.
- Quality Assurance or Regulatory Compliance experience in printing/label industry is a plus!
- Familiarity with change man.
- Leading teams.
- Familiarity with Lean Six Sigma concept.
- Familiarity with the implementation and sustainability of ISO 9001 or other regulated industry standards.
WORK ENVIRONMENT/PHYSICAL DEMANDS:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee primarily works in an office environment. The employee is frequently required to enter and work on the production area of the facility with exposure to loud noises and moving equipment, and Personnel Protection Equipment (PPE) adherence would be required.
OTHER DUTIES:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Why Join SATO?
SATO offers a comprehensive benefits package designed to support your health, financial well-being, and work-life balance.
Health & Wellness
- Medical, dental, and vision coverage.
- Domestic partner coverage available.
- Company-paid life insurance, AD&D, short-term disability, and long-term disability.
- Health Savings Account (HSA) with employer contribution.
Time Away
- 10 company-paid holidays.
- 15 days of accrued vacation.
- 6 accrued personal days annually.
Financial Security
- 401(k) with company match.
- Immediate vesting after eligibility requirements are met.
Professional Growth
- Career development opportunities.
- Employee Assistance Program.
- Referral bonus opportunities.