Job Overview:
The Quality Engineer will be responsible for initiating and performing defined quality activities leading to new or improved processes or systems.
Key Responsibilities Include:
* Initiating, reviewing, and approving change controls
* Maintaining compliance with product manufacturing, packaging, and labeling standards
* Developing sampling strategies and implementing effective methods
* Collaborating on CAPAs, NC/NCMRs, and SCARs to address compliance issues
* Conducting internal and supplier audits
* Supporting external regulatory body audits, including ISO and FDA
* Completing relevant training and adhering to associated documentation
* Fostering a culture of environmental, health, and safety awareness
* Ensuring adherence to CGMP requirements
Requirements:
* Degree in Quality, Science, or Engineering is required
* Minimum three years experience working in regulated environments, specifically medical device, FDA, or ISO 13485 registered work environments
* Medical device change control implementation
* Proficiency in computer skills (MS Excel, PowerPoint, Word)
* Familiarity with statistical tools such as Pareto charts and trend charts
* Familiarity with FMEA's and root cause analysis tools
* Strong problem-solving skills
* Effective communication of technical information to both non-technical and technical associates
* Able to work within a fast-paced team environment