Quality Assurance Engineer - Regulated Manufacturing

Intepros; Portage (MI); Sur place; USD 60 000 - 85 000; Plein temps

Résumé du poste

Intepros is seeking a Quality Assurance Engineer to support QA, quality control, and continuous improvement across manufacturing processes. You will collaborate with Operations, Engineering, and suppliers to investigate issues, manage CAPAs, and enhance product quality in a regulated environment.

This role is ideal for an early-career QA professional looking to build experience in a compliant manufacturing setting, with opportunities to impact material review boards, supplier changes, and

Qualifications

• Bachelor's degree required.
• 0–2 years in Quality Assurance/Quality Engineering in a regulated industry preferred.
• Familiarity with ISO 13485, GDP, and GMP.
• Understanding of CAPA, risk management, audits, and statistical methods.
• Proficiency with MS Word, Excel, and PowerPoint.
• Strong analytical and communication skills.
• High attention to detail and ability to manage multiple priorities.

Responsabilités

• Partner with Operations and cross-functional teams to maintain product and process quality.
• Manage internal and supplier nonconformances, investigations, and timely resolution.
• Support CAPAs, root cause analysis, and SCARs.
• Support MRB activities and disposition of nonconforming products.
• Review and support change management activities for suppliers, products, and processes.
• Develop, review, and update quality procedures and documentation.
• Monitor quality KPIs, analyze trends, and implement corrective actions.
• Support manufacturing complaints, product field actions, holds, and containment plans.
• Apply statistical methods to process analysis and quality control.
• Support audits, process validation, equipment qualification, and MSA.
• Perform quality activities related to engineering changes, supplier changes, and transfers.
• Support risk management, Lean initiatives, standardization, and waste reduction.
• Apply Human Error Prevention principles in manufacturing.

Connaissances

Quality assurance

CAPA

Risk management

Statistical methods

Problem solving

Analytical skills

Formation

Bachelor's degree

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

Intepros is seeking a Quality Assurance Engineer to support QA, quality control, and continuous improvement across manufacturing processes. You will collaborate with Operations, Engineering, and suppliers to investigate issues, manage CAPAs, and enhance product quality in a regulated environment.

This role is ideal for an early-career QA professional looking to build experience in a compliant manufacturing setting, with opportunities to impact material review boards, supplier changes, and