Associate Quality Engineer

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.