Position: Quality Engineer
The Quality Engineer will be responsible for ensuring all quality-related aspects of the manufacturing process run smoothly and effectively. This role will support quality initiatives, compliance efforts, and process improvements to maintain high manufacturing standards.
Reporting to the Quality Manager, the Quality Engineer will contribute to achieving the organization’s quality objectives while maintaining compliance with relevant industry regulations.
Key Responsibilities:
1. Develop and implement solutions to sustain and enhance the Quality Management System (QMS).
2. Ensure compliance with ISO 13485 and ISO 14001 standards.
3. Collaborate with customers on new product introductions, quality concerns, and process qualifications.
4. Implement process control measures to meet customer and regulatory requirements.
5. Conduct process validations and product qualifications.
6. Provide quality expertise and support for manufacturing operations, including product disposition.
7. Analyze quality data and trends to identify preventive strategies for reducing non-conformances and risks.
8. Lead and coordinate Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPA) to ensure timely resolution.
9. Facilitate training programs on quality procedures, including compliance, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and audit preparation.
10. Assist in internal audits and represent the site during external audits.
11. Monitor and track quality metrics to drive continuous improvement.
12. Support Environmental, Health, and Safety (EHS) initiatives and training.
13. Perform additional responsibilities as assigned by management.
Qualifications & Key Attributes:
1. Bachelor's degree in Engineering, Polymer Science, or equivalent experience in manufacturing.
2. Proficiency in statistical analysis (e.g., Minitab), Statistical Process Control (SPC), and validations.
3. Strong communication, interpersonal, and problem-solving skills.
4. Minimum of 3 years of experience in Quality Assurance Engineering, preferably in injection molding or medical device manufacturing.
How to apply:
nfordyce@barringtonjames.com
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