Required Education:

• Bachelor's DegreeRequired Skills:

• 0-2 years' experience in a Quality or Regulatory Affairs role; prior industry experiences desirable.
• Familiar with ISO 13485, GDP, and GMP concepts.
• Solid understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Strong problem-solving, analytical, and communication skills with high attention to detail.
• Builds strong relationships through open communication, respect, and trust.
• Team player with a customer/stakeholder-focused approach.
• Diplomatic, tactful, and effective at leveraging interpersonal skills.
• Embraces change with a continuous improvement mindset.
• Excellent written and spoken English.
• Confident representing Quality in cross-functional settings.
• Self-starter able to manage multiple tasks in a fast-paced environment.
• Willing to work as part of a multi-site team; some travel required.
• Knowledge of risk-based thinking and statistical concepts is a plus.

Overview:

The Engineer, Quality Assurance will play a proactive role in supporting quality assurance, quality control and preventive activities to ensure compliance with regulations and standards. Collaborate with cross-functional teams, assist in resolving quality issues, and contribute to continuous improvement initiatives within manufacturing and quality processes.

Quality Assurance Engineer -

CAPA, Supplier Quality & Manufacturing:

• Work closely with Operations and Business Functions to ensure 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) through root cause analysis to closure
• Disposition of non-conforming product through MRB, 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 (both supplier and internal)
• Create and/or review new or revised procedures
• Maintain and analyze 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 QA support during internal and external audits
• Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
• Execute internal quality deliverables for engineering changes, manufacturing transfers, and supplier changes
• Assist in manufacturing/product transfers between plants/facilities, performing appropriate quality activities
• Execute and analyze Quality Acceptance Tests (QATs)
• Support with product holds and executing containment Plans
• Support in risk management practices and tools, use knowledge in process risk. Support and provide input for risk management by identifying opportunities and weaknesses.
• Support and implement Lean principles through standardization and waste elimination
• Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
• Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services.
• 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.

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