Schott North America
About us
Your Contribution
Your Profile
Your Contribution
- Lead Quality Engineering and TCS departments
- Validate and re-revalidation of sterilization processes
- Manage the validation process
- Support experimental and validation protocols for equipment, processes and materials
- Manage the supplier quality management process
- Manage the process for customer driven changes and site transfers
- Manage the process for developing product specifications and quality attributes
- Support audits and prepare responses
- Coordinate Customer Quality Agreements
- Establish EM program
- Perform risk assessments
- Assign and/or manage CAPAs
- Bachelor's Degree in Engineering, or related field, required
- Minimum (5) years of experience as a Quality Engineer
- Minimum (3) years of leadership experience in sterile product/process investigations, validations, instrument qualifications, customer support and EM
- Solid knowledge of ISO 9001, 14001, 15378, along with cGMP
- Experience in glass forming industry and/or pharmaceutical industry, preferred
- Sound computer knowledge and skills including MS Office, SAP and Minitab
- Multi-tasking abilities and prioritization
- Detail oriented approach; forward/creative thinking
- Positive team approach and ability to lead others
- Effective communication skills
- Ability to read, write and speak English language
- Excellent healthcare benefits including medical, dental and vision
- Short and long term disability
- Tuition reimbursement
- Paid time off
- Pet insurance
- Other supplemental benefits available upon election
Your Profile
- Bachelor's Degree in Engineering, or related field, required
- Minimum (5) years of experience as a Quality Engineer
- Minimum (3) years of leadership experience in sterile product/process investigations, validations, instrument qualifications, customer support and EM
- Solid knowledge of ISO 9001, 14001, 15378, along with cGMP
- Experience in glass forming industry and/or pharmaceutical industry, preferred
- Sound computer knowledge and skills including MS Office, SAP and Minitab
- Multi-tasking abilities and prioritization
- Detail oriented approach; forward/creative thinking
- Positive team approach and ability to lead others
- Effective communication skills
- Ability to read, write and speak English language
- Lead Quality Engineering and TCS departments
- Validate and re-revalidation of sterilization processes
- Manage the validation process
- Support experimental and validation protocols for equipment, processes and materials
- Manage the supplier quality management process
- Manage the process for customer driven changes and site transfers
- Manage the process for developing product specifications and quality attributes
- Support audits and prepare responses
- Coordinate Customer Quality Agreements
- Establish EM program
- Perform risk assessments
- Assign and/or manageCAPAs