Senior QA Specialist: CAPA & Continuous Improvement

Ergodyne; Saint Paul (MN); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Ergodyne, a Minnesota-based manufacturer, seeks a Quality Assurance Specialist to develop and maintain our quality management systems, ensuring products meet internal standards, customer expectations, and regulatory requirements. You will lead QA processes, drive continuous improvement, and collaborate across teams to foster a culture of quality.

The role requires 5+ years in QA in manufacturing, a bachelor's degree, and strong analytical and leadership skills.

Qualifications

• 5+ years of quality assurance in manufacturing.
• Bachelor's degree in engineering, quality management, manufacturing, or related field.
• Strong knowledge of quality management systems, audits, compliance, and documentation.
• Experience in inspection, testing, statistics, specification understanding, and supplier audits (PPAP QPQP).

Responsibilities

• Serve as liaison between suppliers, product management, compliance, and inventory management to address non-conformity issues.
• Champion the formal corrective and preventative action (CAPA) for products that don't meet requirements or expectations.
• Oversee incoming supplied product inspections for new product launches and ongoing production units to ensure product quality.
• Work with product management to ensure new product requirements and quality standards are clearly communicated to suppliers and checked throughout production and receiving processes.
• Parter with sourcing team to assess and approve suppliers for current and future sourcing activities.
• Work cross-functionally with compliance and other departments to create and execute product sampling and testing plans to measure product quality and resolve CAPAs.
• Partner with compliance department to ensure compliance with applicable standards and regulatory requirements.
• Lead warranty analysis reviews.
• Analyze data to establish and monitor metrics, KPIs, and reporting systems related to product quality.
• Coordinate with operations and product management to implement continuous improvement initiatives to reduce defects, waste, and operational inefficiencies.
• Execute and improve Ergodyne's quality management system and internal audit process
• Provide training and guidance across the organization to strengthen quality awareness and best practices.

Skills

Quality management

Root cause analysis

Six Sigma

Lean

Project management

Communication

Education

Bachelor's degree

Job description

Ergodyne, a Minnesota-based manufacturer, seeks a Quality Assurance Specialist to develop and maintain our quality management systems, ensuring products meet internal standards, customer expectations, and regulatory requirements. You will lead QA processes, drive continuous improvement, and collaborate across teams to foster a culture of quality.

The role requires 5+ years in QA in manufacturing, a bachelor's degree, and strong analytical and leadership skills.