Honeywell Sr Advanced Quality Engineer Relocation 

United States 

8058796

The future is what you make it.

Be a part of a cross-functional team working with processdevelopment, toller management, customer interaction, and regulatoryrequirement at the Pottsville, PA site. This role will apply expertiseand knowledge in finding innovative, cost-effective means to improve qualityoutput and continuous improvements. You will drive process initiatives thatensures compliance with customer requirements, regulatory agencies, governmentregulations and engineering specifications while instilling accountability forgovernance of the Quality System, product acceptance and, product quality fromdevelopment through day-to-day production.

Key Responsibilities

• Process Development
• Develop specifications for all SKUs
• Develop and validate test methods
• Specify testing and validation protocol for new SKUs

Toller Management

• Assess quality systems of potential tolling partners
• Develop toller quality management processes
• Monitor ongoing Cpks at tollers
• Lead continuous improvement efforts
• Cost improvement analysis
• Drive technical solutions for quality improvements

Customer Interaction

• Assist/Lead projects to improve product quality
• Lead customer audits
• Work with customers and tollers to resolve customer complaints
• Generate certificate of analysis for customers

Regulatory

• Perform regulatory reviews
• Work with Product Stewardship for regulatory needs
• Perform risk analyses

Analytical Equipment service and calibration

• Perform analytical equipment maintenance and calibration
• FT-IR Validations
• Analytical Balances
• Agilent GC CTFE standards
• Minolta Meter
• Die Line Camera
• WaveScan Dual
• HazeGard
• ZST timers and temperature checks
• Oven temperature checks
• Pycnometers
• Emveco micrometer
• Tape Rules
• Steel Rules
• Analytical Testing
• WVTR
• Film Surface Energy
• Film Properties

YOU MUST HAVE

• Bachelors Degree in Engineering
• Minimum 2 years working in cGMP environment
• Six Sigma certification
• Proficient computer skills
• Statistical analysis skills (Excel, Minitab, and other statistical tools)

WE VALUE

• Process Development skills and experience
• Experience with testing, validations, Customer CAPA process, Process Capability
• Compliance Knowledge in Pharma
• Proficiency in regulatory investigations
• Knowledge of pharma regulatory compliance guidelines, international regulation familiarity FDA, EMA, ANVISA, CFDA,
• Japan Ministry of Health
• Hands on work ethic
• Provide clear and concise communications
• Ability to work independently
• Ability to partner with others on projects
• Ability to travel 25% of time, both domestic and international
• Understanding of quality processes
• Film manufacturing experience
• Lead Quality Auditor skills

• JOB ID: HRD235299
• Category: Integrated Supply Chain
• Location: 98 Westwood Rd,Pottsville,Pennsylvania,17901,United States
• Exempt
• Due to US export control laws, must be a US citizen, permanent resident or have protected status.