Quality Systems Engineer – ISO 13485 & CAPA Lead

Company; Vadnais Heights, Northern (MN, KY); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Seaway Plastics seeks a Quality Engineer to support and improve quality activities for assigned programs in a regulated manufacturing setting. You will lead validation efforts (IQ/OQ/PQ), create control plans, and act as the primary quality contact for customers while coordinating CAPA activities.

The role requires a BS in Engineering and 4+ years of relevant experience, with strong problem-solving and cross-functional collaboration skills. On-site in Vadnais Heights, Minnesota.

Qualifications

• BS in Engineering or equivalent.
• 4+ years in a regulated manufacturing environment.
• Experience executing IQ, OQ, and PQ validation activities.
• Knowledge of ISO 13485 and FDA QSR is preferred.
• Experience supporting customer audits and quality discussions.

Responsibilities

• Supports development and sustaining quality activities for assigned programs, including validation.
• Participates in Stage-Gate product realization processes.
• Leads/executes validation protocols (IQ/OQ/PQ) and reports.
• Prepares Process Flow Diagrams, FMEAs, and Control Plans.
• Acts as primary quality contact for customers and CAPA management.
• Supports NCR, MRB, SCARs, and sustainment programs.
• Drives continuous improvement using Lean/Six Sigma and data analysis.
• Leads cross-functional problem-solving events (8D, DMAIC, A3).
• Coaches operators on quality tools and standard work.

Skills

Stage-Gate

IQ/OQ/PQ execution

Root cause analysis

Lean Six Sigma

8D/DMAIC/A3

ISO 13485 / FDA QSR

Cross-functional collaboration

Education

BS in Engineering

Tools

Epicor ERP

Job description

Seaway Plastics seeks a Quality Engineer to support and improve quality activities for assigned programs in a regulated manufacturing setting. You will lead validation efforts (IQ/OQ/PQ), create control plans, and act as the primary quality contact for customers while coordinating CAPA activities.

The role requires a BS in Engineering and 4+ years of relevant experience, with strong problem-solving and cross-functional collaboration skills. On-site in Vadnais Heights, Minnesota.