About us
Your Contribution
- Lead process mapping and continuous improvement activities
- Perform site based risk assessments
- Support quality control plan analysis and improvements
- Coordinate, collect and analyze data for customers; troubleshoot and resolve customer issues; provide root cause analysis and corrective action
- Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions
- Ensure execution of global CAPA(s)
- Complete trend analysis for quality data
- Prepare customer audit finding responses
- Serve as internal and/or supplier auditor
- Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports
- Develop and document best practice methods
- Train where applicable, and model cGMP
- Assist in customer audits and inspections
- Assure compliance with ISO certifications and Company policies/Code of Conduct
Your Profile
- Bachelor’s Degree in Mechanical, Materials or Industrial Engineering, or related field, required
- Minimum (5) years of experience within a Quality Engineer role
- Solid knowledge of ISO 9001, 13485 and 15378, along with cGMP and validation, preferred
- Experience in glass forming industry and/or pharmaceutical industry, preferred
- Sound computer knowledge and skills including MS Office and SAP
Your Benefits
- Excellent healthcare benefits including medical, dental and vision
- Short and long term disability
- Tuition reimbursement
- Pet insurance
- Paid time off
- Other supplemental benefits available upon election
Please feel free to contact us
Application tips
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Quality Engineer
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