Associate Quality Engineer: QA, Validation & Improvement

Seaway Plastics; Hoffmans Corner, Willow Lake (MN, SD); On-site; USD 55,000 - 70,000; Full time

Job summary

Seaway Plastics in Minnesota seeks a Quality Engineer I to support development and sustaining quality activities for assigned programs, participate in Stage-Gate product realization, and assist with validation activities under the guidance of experienced Quality and Engineering team members.

You will support quality planning, CAPAs, audits, data analysis, and continuous improvement using Lean/Six Sigma, collaborating across Manufacturing, Engineering, Production, and Supply Chain to resolve

Qualifications

• Bachelor's degree in engineering or a related technical discipline preferred. Recent graduates are encouraged to apply.
• 0-2 years of experience in quality, engineering, manufacturing, or a related technical environment preferred. Relevant internships, co-op experience, or academic projects may be considered.
• Exposure to or an interest in learning process validation activities, including IQ, OQ, and PQ.
• Familiarity with quality systems or regulated manufacturing environments is a plus.
• Exposure to ISO 13485, FDA quality requirements, cGMP, or cGDP is preferred but not required.

Responsibilities

• Support development and sustaining quality activities for assigned programs, including part validation, qualification, and ongoing compliance.
• Participate in the organization's Stage-Gate approach to product realization and new product introduction.
• Assist with validation activities, including IQ, OQ, and PQ protocols and reports, under the guidance of experienced Quality and Engineering team members.
• Support quality planning activities, including Process Flow Diagrams, Process FMEAs, Control Plans, work instructions, and inspection instructions.
• Assist with customer quality concerns, investigations, documentation, and corrective actions.
• Participate in CAPAs, SCARs, RMAs, and other quality improvement activities.
• Support the review and disposition of internally produced nonconforming material.
• Work collaboratively with Manufacturing, Engineering, Production, and Supply Chain teams to identify and resolve quality issues.
• Participate in internal, customer, ISO 13485, and regulatory audits, including audit preparation, documentation, and follow-up activities.
• Analyze quality and production data to identify trends and opportunities to improve product and process performance.
• Support continuous improvement initiatives using Lean/Six Sigma principles to help reduce defects, scrap, rework, and customer complaints.
• Participate in structured problem-solving activities such as 8D, DMAIC, A3, and root cause analysis, with guidance from senior team members.
• Assist Production, Engineering, and Processing teams with updating Control Plans, work instructions, inspection methods, and other quality documentation.
• Support shop-floor quality initiatives and help reinforce adherence to established processes, procedures, and quality standards.
• Assist with NCR and MRB activities, including investigation, documentation, disposition, risk assessment, corrective actions, and closure.
• Develop knowledge of quality engineering tools, regulatory requirements, manufacturing processes, and continuous improvement methodologies through hands‑on experience and mentorship.

Skills

Quality engineering

Analytical skills

Cross-functional teamwork

Attention to detail

Reading engineering drawings

Problem-solving

Education

Bachelor's degree in engineering or related technical discipline

Tools

Excel

ERP systems (Epicor)

Document control systems

MS Office

Job description

Seaway Plastics in Minnesota seeks a Quality Engineer I to support development and sustaining quality activities for assigned programs, participate in Stage-Gate product realization, and assist with validation activities under the guidance of experienced Quality and Engineering team members.

You will support quality planning, CAPAs, audits, data analysis, and continuous improvement using Lean/Six Sigma, collaborating across Manufacturing, Engineering, Production, and Supply Chain to resolve