What are the responsibilities and job description for the Quality Engineer I position at Coghlin Companies?
Quality Engineer I Role at Coghlin Companies
We are on a mission to deliver world-class medical devices and need a detail-oriented Quality Engineer I to ensure compliance and drive continuous improvement in all our processes.
If you're passionate about quality, problem-solving, and making a real impact in the medical device industry, this is the role for you.
Key Responsibilities:
- Promote strict adherence to quality standards at all levels.
- SUPPORT process qualification, new product introductions, and guarantee all products meet quality standards.
- Drive continuous improvement by analyzing metrics like First Pass Yield (FPY) and On-Time Delivery, and work with teams to resolve issues.
- Lead root cause analysis for customer complaints and CAPAs using tools like PFMEA, Ishikawa, and more.
- Write, implement, and manage Corrective and Preventive Actions (CAPAs) to address quality issues and drive improvements.
- Collaborate and support cross-functional teams on supplier quality to production processes, ensuring quality at every stage.
- Play a key role in product success teams and manufacturing launches, ensuring quality from day one.
Requirements:
- Self-motivated with a passion for delivering high-quality results.
- 2 years in medical device manufacturing, with knowledge of ISO-13485 and electro-mechanical assemblies.
- Strong problem-solving ability, excellent communication, and intermediate MS Office skills (Excel, Word, Visio).
- Bachelor's degree in a relevant field. Biomedical Engineering degree is preferred.
- Familiarity with IPC-610/620 standards and cGMP environments is a plus.
About Us:
- Be part of a dynamic, innovative team dedicated to improving lives through medical technology.
- Growth opportunities to advance your career in a fast-paced, rewarding environment.
- Competitive benefits and compensation package.
