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Quality Engineer
2 months ago
Are you passionate about ensuring high-quality, reliable products? Join our client as a Quality Engineer
About the Role
As a Quality Engineer, you’ll ensure their medical devices, materials, components, and manufacturing processes produce top-tier products. You’ll develop and implement methods to inspect, test, and evaluate product reliability.
Key Responsibilities
- Quality Assurance: Ensure materials and processes produce high-quality products.
- Inspection & Testing: Develop inspection criteria and verify conformance with specifications.
- Method Development: Create sampling, inspection, and testing methods using statistical tools.
- Collaboration: Integrate quality considerations into manufacturing procedures and training.
- Equipment Management: Maintain and coordinate equipment calibrations.
- Customer Interaction: Participate in customer specifications and risk assessments.
- Team Leadership: Lead teams in investigating quality issues and managing the CAPA program.
- Training: Provide training to quality assurance team members.
- Communication: Interact with customers to support quality objectives.
What We're Looking For
- Education: Bachelor’s degree in a scientific or engineering field.
- Experience: 3+ years in a quality engineering role in the medical device industry or similar.
- Regulatory Knowledge: Experience with Quality Management Systems (ISO 9001, ISO 13485, FDA QSR, cGMP 21 CFR Part 820, ISO 14971).
- Technical Skills: Proficiency in Microsoft Office and database management; SolidWorks or 3D CAD skills are a plus.
- Communication: Excellent written and verbal skills in English.
- Analytical Skills: Strong problem-solving and decision-making abilities.
- Certifications: Six Sigma, CQE, or CQA preferred.
Why Join Us?
Our client offers a collaborative, innovative environment where your contributions are valued. Lead significant quality initiatives and work with a dedicated team committed to excellence.
Company DescriptionBreakaway Consultants is an executive search firm that represents many industries across the nation, we pride ourselves in finding the right fit for employees and employers.Company DescriptionBreakaway Consultants is an executive search firm that represents many industries across the nation, we pride ourselves in finding the right fit for employees and employers.
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