Position Overview:
The Quality Engineer is responsible for ensuring product and process quality across all phases of the manufacturing lifecycle, from development and validation through production and continuous improvement. This role applies quality engineering tools and risk management practices to drive compliance, consistency and efficiency within a regulated manufacturing environment.
Key Responsibilities
Lead Quality Planning & Validation
- Apply APQP principles and manage IQ/OQ/PQ validation to ensure quality is built into new product launches and process changes.
Implement Risk & Control Strategies
- Develop and maintain risk management tools (e.g., pFMEA) and control plans to ensure consistent product performance and mitigate potential quality issues.
Drive Inspection & Testing Protocols
- Create and manage standards for inspection, testing and evaluation of materials and processes, including sampling plans and data recording systems.
Support Continuous Improvement
- Collaborate with cross-functional teams to identify and implement process improvements using formal problem-solving tools (e.g., 8D, root cause analysis, CAPA).
Ensure Compliance & Quality Systems Adherence
- Maintain alignment with ISO 13485 and FDA cGMP standards, supporting audits and documentation as part of the broader quality management system.
Qualifications
Bachelor's degree in engineering or a related technical field (or equivalent experience: 2-4 years in a similar role).