NEW JOB OPENING
QUALITY ENGINEER MEDICAL DEVICE MANUFACTURING
IN Portage, MI, USA!

Required Education

• Bachelor’s degree in engineering, Science, or a related technical field



Required Qualifications/Skills/Experience:

• 1–2 years of experience in Quality Assurance, Quality Engineering, or Regulatory Affairs.

• Familiarity with ISO 13485, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP).

• Understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistical Methods.

• Knowledge of non-conformance management, root cause analysis, corrective and preventive actions, and quality investigations.

• Experience supporting manufacturing quality processes, product quality, and supplier quality activities.

• Strong problem-solving, analytical, organizational, and communication skills with high attention to detail.

• Proficiency in Microsoft Word, Excel, and PowerPoint.

• Excellent written and spoken English communication skills.

• Ability to manage multiple tasks independently in a fast-paced environment.

• Ability to collaborate effectively with cross-functional and multi-site teams.

• Willingness to travel as required.

• Ability to represent Quality confidently in cross-functional settings.



Preferred Qualifications/Skills/Experience:

• Previous experience in medical devices, manufacturing, or other regulated industries.

• Knowledge of risk-based thinking, statistical concepts, and process risk management.

• Familiarity with supplier quality management and Supplier Corrective Action Requests (SCARs).

• Understanding of Lean principles, continuous improvement, and waste elimination.

• Knowledge of Human Error Prevention principles and their application in manufacturing environments.

• Experience with process validation, equipment qualification, Measurement System Analysis (MSA), and manufacturing transfers.



Quality Engineer Overview:

The Quality Engineer supports manufacturing and product quality activities by working closely with Operations, Engineering, suppliers, and other business functions. This role focuses on maintaining product and process quality, managing non-conformances, supporting CAPA investigations, and driving continuous improvement initiatives. The position also contributes to risk management, supplier quality, manufacturing process improvements, and compliance with applicable quality standards and regulatory requirements.



Job Duties:

• Collaborate with Operations and business functions to ensure quality performance of products and manufacturing processes.

• Work cross-functionally with internal teams and external suppliers to investigate and resolve quality issues.

• Manage internal and supplier-related Non-Conformances (NCs), ensuring timely investigation, documentation, and closure.

• Support and manage Corrective and Preventive Actions (CAPAs), including root cause analysis and implementation of corrective actions.

• Review and disposition non-conforming products through Material Review Board (MRB) processes and issue NCs as required.

• Communicate with suppliers regarding non-conformances and initiate or escalate Supplier Corrective Action Requests (SCARs) when necessary.

• Support the development and continuous improvement of manufacturing processes for existing products.

• Review and support internal and supplier-related Change Management activities.

• Create, review, and revise quality procedures and documentation.

• Monitor and analyze quality KPIs to identify trends, evaluate performance, and implement corrective actions.

• Support the investigation and analysis of manufacturing complaints and product field actions.

• Apply statistical methods for process analysis, monitoring, and control.

• Provide Quality Assurance support during internal and external audits.

• Support process and equipment validation, qualification, and Measurement System Analysis (MSA).

• Execute quality deliverables related to engineering changes, manufacturing transfers, and supplier changes.

• Support product and manufacturing transfers between plants and facilities by completing required quality activities.

• Assist with product holds, containment plans, and related quality investigations.

• Support risk management activities by identifying process risks, weaknesses, and opportunities for improvement.

• Implement Lean principles through process standardization, waste elimination, and continuous improvement.

• Apply Human Error Prevention principles within the manufacturing environment.

• Manage supplier relationships, coordinate communications, and monitor supplier quality performance.

• **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

• **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**