Entry Level Manufacturing Quality Assurance Engineer

We are hiring Entry Level Manufacturing Quality Assurance Engineer.

Please let me know if you are interested or anyone who might be interested.

Client: Major Medical Device Client

Position: Entry Level Manufacturing Quality Assurance Engineer

Duration: 12 months on W2

Location: Portage, Michigan 49002

Pay Rate: $35.00-$50.00/ Hr on W2

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Job Description

Position Summary

The Engineer, Quality Assurance will play a proactive role in supporting quality assurance, quality control, and preventive activities to ensure compliance with applicable regulations and standards.

The role involves collaborating with cross-functional teams, assisting in resolving quality issues, and contributing to continuous improvement initiatives within manufacturing and quality processes.

Essential Duties & Responsibilities

• Work closely with Operations and Business Functions to ensure the quality performance of products and processes.
• Collaborate cross-functionally with internal and external teams to resolve quality issues.
• Own and manage internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure.
• Support or own Corrective and Preventive Actions (CAPAs), from root cause analysis through closure.
• Disposition non-conforming products through the Material Review Board (MRB) process, issuing NCs as appropriate.
• Communicate with suppliers regarding NCs and escalate Supplier Corrective Action Requests (SCARs) as needed.
• Participate in the development and continuous improvement of internal manufacturing processes for existing products.
• Review and support Change Management activities, including supplier and internal changes.
• Create and/or review new or revised procedures.
• Maintain and analyze Key Performance Indicators (KPIs) to monitor product and process quality, identify trends, and implement corrective actions.
• Support the execution and analysis of manufacturing complaints and product field actions.
• Apply statistical methods for process analysis and control.
• Provide Quality Assurance (QA) support during internal and external audits.
• Support process and equipment validation, qualification, and Measurement System Analysis (MSA).
• Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes.
• Assist with manufacturing and product transfers between plants or facilities, performing appropriate quality activities.
• Execute and analyze Quality Acceptance Tests (QATs).
• Support product holds and execute containment plans.
• Support risk management practices and tools, applying knowledge of process risks and providing input by identifying opportunities and weaknesses.
• Support and implement Lean principles through standardization and waste elimination.
• Understand Human Error Prevention principles and their application in the manufacturing environment.
• Manage supplier relationships, including coordinating communications, monitoring performance, managing internal and external nonconformities, and ensuring timely delivery of quality materials and services.

Education & Special Training

• Bachelor's degree.

Qualifications & Experience

• 1 years of experience in a Quality or Regulatory Affairs role; prior industry experience is desirable.
• Familiarity with ISO 13485, Good Distribution Practices (GDP), and Good Manufacturing Practices (GMP) concepts.
• Solid understanding of engineering and quality principles, including Risk Management, CAPA, audits, and statistical methods.
• Proficiency in Microsoft Word, Excel, and PowerPoint.
• Strong problem-solving, analytical, and communication skills, with high attention to detail.
• Ability to build strong relationships through open communication, respect, and trust.
• Strong team player with a customer- and stakeholder-focused approach.
• Diplomatic, tactful, and effective in leveraging interpersonal skills.
• Adaptable and committed to continuous improvement.
• Excellent written and spoken English communication skills.
• Confidence in representing Quality in cross-functional settings.
• Self-starter with the ability to manage multiple tasks in a fast-paced environment.
• Willingness to work as part of a multi-site team; some travel may be required.
• Knowledge of risk-based thinking and statistical concepts is an advantage.

Regards

Vishnu Das Natesan

dvishnu@radiants.com