What are the responsibilities and job description for the 🔍 Quality Engineer – Isolators and Equipment at Germfree – Innovating with Precision! position at Germfree?
Who We Are:
At Germfree, we specialize in manufacturing critical environment equipment and facilities that have a real-world impact. Grit, integrity, ownership, and innovation are at the heart of everything we do. As a Quality Engineer – Isolators and Equipment, you’ll play a pivotal role in ensuring the highest standards of quality for our products, from medical devices to biosafety equipment.
This role is perfect for a detail-oriented problem-solver who thrives in a fast-paced environment and is passionate about continuous improvement. If that sounds like you, we want YOU on our team!
What You’ll Do:
- Plan & Execute Quality Testing: Develop quality testing plans by reviewing client URS (user requirements) and setting detailed guidelines based on quality standards.
- Update & Monitor QMS: Maintain and improve the Quality Management System (QMS) with incidents, fixes, and enhancements.
- Set Metrics: Define and monitor quality metrics for all manufacturing procedures.
- Inspect & Test: Monitor the entire production cycle, inspect MEP (mechanical, electrical, and plumbing) systems for defects, and conduct tests to identify potential malfunctions early.
- Root Cause Analysis: Identify technical issues, perform root cause analyses, and recommend corrective actions.
- Prepare Documentation: Create detailed reports on malfunctions, corrective actions, and quality improvements.
- Coordinate Compliance: Work with internal teams and external quality auditors to ensure compliance with industry and legal standards.
- Blueprint Review: Examine blueprints and quality documentation to ensure product integrity.
- Continuous Improvement: Utilize Lean principles and other continuous improvement strategies to enhance processes and product quality.
What You’ll Bring:
- Education: Bachelor’s degree in mechanical, manufacturing, industrial, or production engineering (preferred) or a related field.
- Experience:
- 3-5 years in a related role.
- Experience in Pharmaceutical, Biotech, Aerospace, Biosafety, Food Processing, or similar industries.
- Understanding of aseptic processing equipment and clean room standards.
- Familiarity with mechanical, electrical, plumbing, and control systems.
- Skills:
- Ability to interpret blueprints and technical specifications.
- Strong analytical and critical-thinking skills with the ability to conduct root cause analyses and implement preventive actions.
- Proficiency with Microsoft Office Suite (Word, Excel, Outlook).
- Excellent communication skills, both written and verbal, to clearly document and communicate processes.
- A strong work ethic with the ability to meet deadlines under pressure.
Bonus Points If You Have:
- Experience working with ISO9001 compliance and quality standards.
- Knowledge of Lean Manufacturing principles and practices.
- A passion for driving continuous improvement in a collaborative environment.
Why You’ll Love It Here:
At Germfree, we’re dedicated to creating a work environment where you can thrive and make a difference. You’ll collaborate with passionate professionals, work on exciting projects, and help ensure the quality and reliability of our cutting-edge products. Alongside competitive pay and benefits, you’ll also enjoy:
- Health Insurance – because your health matters.
- 401K Company Match – securing your future with us.
- Pet Insurance – because furry family members matter too! 🐾
- Parental Leave – supporting you during life’s most important moments.
- Unlimited Coffee – fuel your focus and innovation. ☕
- Food Truck Thursdays – tasty treats to keep things fun. 🌮
- In-house Canteen – enjoy meals without leaving the office.
- Dog-friendly Office – bring your furry friend and enjoy our on-site dog park! 🐶
Join Germfree as a Quality Engineer and help us maintain the highest standards while shaping the future of critical environment manufacturing. Apply today!
