What are the responsibilities and job description for the Quality Engineer position at Schott North America?
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
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 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
SCHOTT North America, Inc. is an Equal Opportunity/Affirmative Action Employer. Applicants considered without any regard to race, color, creed, religion, age, national origin, ancestry, ethnicity, gender, gender identity, gender expression, sexual orientation, marital status, veteran status, disability, genetic information, citizenship status or membership in any other group protected by federal, state or local law. Any form of unlawful harassment is prohibited.
