Job Description
Quality Engineer | Medical Device Industry
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12-Month+ Contract | 1st Shift | Monday-Friday, 8:00 AM-5:00 PM ET | Hybrid | 3 Days Onsite
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Our client, a global leader in the medical device industry, is seeking a Quality Engineer to support quality assurance, process control, validation, and continuous improvement within a highly collaborative manufacturing environment.
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This is a great opportunity for a quality professional who enjoys working cross-functionally and making a direct impact on product quality, process performance, and regulatory compliance.
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Key Focus
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- Quality Engineering
- Process Control & Improvement
- Validation & Change Control
- PPAP & First Article Inspection
- Quality Management Systems
- SOPs & Inspection Plans
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What You'll Do
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- Provide quality engineering support across quality assurance, quality control, and preventative activities
- Develop and implement methods for process control, improvement, testing, and inspection
- Lead quality initiatives and projects while maintaining compliance with applicable regulations and standards
- Support product transfers and supplier change requests
- Manage PPAP activities for new and modified parts
- Lead validation projects for new equipment and processes
- Develop and execute First Article Inspection (FAI) strategies
- Create and update SOPs and inspection plans through the change management system
- Partner with cross-functional teams and stakeholders to identify and resolve quality issues
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What We're Looking For
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- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related field
- 1+ year of quality engineering or related industry experience
- Experience in medical device manufacturing or another regulated environment
- Strong understanding of Quality Management Systems (QMS) and change management
- Experience with validation activities and change control
- Strong analytical and problem-solving skills
- Excellent written and verbal communication
- Proficiency with Microsoft Word, Excel, and PowerPoint
- Ability to manage multiple priorities in a fast-paced environment
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Interested in learning more? Send me a message or apply today!
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