Associate Quality Engineer

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

KEY ACCOUNTABILITIES:

(The broad spectrum of items that the role is ultimately held accountable for at the end of the day. Results.)

KEY RESPONSIBILITIES:

(The finer details of what the role is assigned for the day-to-day activities on the job. Tasks to support results.)

• 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.

LMA RESPONSIBILITIES:

(Leadership, Management, Accountability)

None

QUALITIES FOR SUCCESS:

(Seaway Core Values, Education, Training, Certifications, Years of experience, Other skills and abilities, Physical Requirements for the Role, etc.)

• Demonstrates Seaway Plastics Core Values
  • We are customer focused
  • We execute
  • We win together
  • We are respectful
• 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.
• Basic understanding of root cause analysis, corrective action, and problem-solving techniques.
• Basic ability to read and interpret engineering drawings and specifications. Exposure to GD&T is preferred.
• Strong analytical skills and attention to detail.
• Good written and verbal communication skills with the ability to work effectively in a cross-functional team environment.
• Ability to manage multiple assignments, prioritize responsibilities, and meet deadlines.
• Experience or exposure to ERP systems such as Epicor is a plus.
• Familiarity with document control, change control, and revision control is preferred.
• Proficiency with Microsoft Office applications, particularly Excel, Word, and PowerPoint.
• Eagerness to learn, take initiative, and develop a career in Quality Engineering.
• Valid identification and ability to legally work in the United States.