Engineer, Quality Assurance

Comrise; Portage (MI); On-site; USD 60,000 - 90,000; Full time

Job summary

Comrise in Portage, MI is seeking a Quality Assurance Engineer. You will support QA, QC and preventive activities within a manufacturing environment, collaborating with Operations, Engineering, suppliers and stakeholders to identify issues and implement corrective and preventive actions.

The ideal candidate is analytical, detail-oriented, and able to work cross-functionally to ensure product quality, regulatory compliance, and continuous improvement across operations.

Qualifications

• Bachelor's degree in a related field.
• 0–2 years of quality assurance/quality engineering experience.
• Familiarity with ISO 13485, GDP, GMP.
• Foundational understanding of risk management, CAPA, audits, and statistics.
• Proficiency in MS Word, Excel, and PowerPoint.
• Excellent written and verbal English communication.

Responsibilities

• Partner with Operations and cross-functional teams to maintain and improve product and process quality.
• Support regulatory compliance and internal quality procedures.
• Assist with internal and external audits.
• Own nonconformances and supplier-related NCs; drive timely resolution.
• Lead or support CAPAs with root cause analysis and corrective actions.
• Apply Lean principles and track KPIs for process improvements.
• Collaborate with suppliers to ensure quality materials and services.

Skills

Analytical thinking

Attention to detail

Problem solving

Written and verbal communication

Cross-functional collaboration

Education

Bachelor's degree

Job description

Work Arrangement: 100% Onsite, Monday–Friday

Position Summary

We are seeking a Quality Assurance Engineer to support quality assurance, quality control, and preventive activities within a manufacturing environment. In this role, you will collaborate with cross-functional teams to ensure product and process quality, maintain regulatory compliance, resolve quality issues, and drive continuous improvement initiatives.

The ideal candidate is analytical, detail-oriented, and comfortable working with Operations, Engineering, suppliers, and other stakeholders to identify issues and implement effective corrective and preventive actions.

Key Responsibilities

Quality Assurance and Compliance

• Partner with Operations and cross-functional business teams to maintain and improve product and process quality.
• Support compliance with applicable regulations, standards, and internal quality procedures.
• Provide quality support during internal and external audits.
• Create, review, and update quality procedures and related documentation.
• Support risk management activities by identifying potential risks, process weaknesses, and opportunities for improvement.

Nonconformance and Corrective Actions

• Own and manage internal and supplier-related nonconformances (NCs), ensuring timely investigation, resolution, and closure.
• Support or lead Corrective and Preventive Actions (CAPAs), including root cause analysis and implementation of effective corrective actions.
• Evaluate and disposition nonconforming products through the Material Review Board (MRB) process, issuing nonconformance reports as appropriate.
• Communicate with suppliers regarding quality issues and **escalate** Supplier Corrective Action Requests (SCARs) when necessary.
• Support product holds and implement appropriate containment plans.
• Assist with manufacturing complaint investigations and product field actions.

Manufacturing and Process Improvement

• Collaborate with manufacturing teams to improve existing processes and maintain consistent product quality.
• Support change management activities involving internal processes and suppliers.
• Assist with process and equipment validation, qualification, and Measurement System Analysis (MSA).
• Execute quality deliverables associated with engineering changes, manufacturing transfers, and supplier changes.
• Support product and process transfers between manufacturing facilities.
• Execute and analyze Quality Acceptance Tests (QATs).
• Apply statistical methods to process analysis, monitoring, and control.
• Track and analyze quality key performance indicators (KPIs), identify trends, and recommend corrective actions.
• Apply Lean principles, standardization, waste reduction, and Human Error Prevention practices to improve manufacturing quality.

Supplier Quality and Collaboration

• Maintain effective supplier relationships through clear communication and collaboration.
• Monitor supplier quality performance and coordinate the resolution of internal and external nonconformances.
• Work with suppliers and internal stakeholders to support the timely delivery of quality materials and services.
• Represent Quality confidently in cross-functional discussions and contribute to a culture of accountability and continuous improvement.

Required Qualifications

• Bachelor's degree required.
• 0–2 years of experience in Quality Assurance, Quality Engineering, or Regulatory Affairs; relevant industry experience is preferred.
• Familiarity with ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).
• Foundational understanding of engineering and quality principles, including risk management, CAPA, audits, and statistical methods.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Excellent written and verbal English communication skills.

Preferred Qualifications and Skills

• Knowledge of risk-based thinking and statistical concepts.
• Strong analytical, problem-solving, and decision-making abilities.
• High attention to detail and commitment to quality.
• Effective communication, interpersonal, and relationship-building skills.
• Ability to work collaboratively with internal teams, suppliers, and other stakeholders.
• Diplomatic and tactful approach to resolving quality issues.
• Self-motivated, adaptable, and able to manage multiple priorities in a fast-paced environment.
• Customer- and stakeholder-focused mindset.
• Willingness to work as part of a multisite team and travel as needed.
• Commitment to continuous improvement, process standardization, and waste elimination.

This position is based onsite in Portage, Michigan, Monday through Friday. The role involves close collaboration with manufacturing operations, engineering, suppliers, and cross-functional quality teams, with some travel required.