Engineer, Quality Assurance

Job Description

Job Description

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 regulations and standards.
Collaborate with cross-functional teams, assist in resolving quality issues, and contribute to continuous improvement initiatives within manufacturing and quality processes.

Essential Duties & Responsibilities: (Detailed Description)
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.

Education & Special Trainings:
Bachelors Degree

Qualifications & Experience:
02 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

Comments for Suppliers:
100% onsite M-F
12 mo assignment - no plan to hire direct, potential for extension but not guaranteed