Quality Engineering Manager

About us

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

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

Your Benefits

• 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

Please feel free to contact us