Quality Project Manager - Validation

Job Title: Quality Project Manager

Responsibilities: 

Pay Range: $110-$125k per year

• Assist Plant Quality Manager in coordinating and executing goals to improve product quality and operating system efficiency
• Direct and coordinate Quality Department employees
• Establish and maintain relationships with production, technology, supply chain, quality teams and cross functional personnel to identify system and compliance gaps with proposed resolutions
• Ensure quality systems meet customer specifications and regulatory requirements
• Manage non-conformities, investigations, problem solving, root cause analysis and corrective actions
• Manage process and equipment Validation for new product and existing business
• Train and develop Quality functional teams
• Engage in customer and third-party visits and audits
• Identify opportunities for improvement through data analysis and implement quality and inspection processes
• Manage Material Review Board activities and participate in CAPA activities
• Coordinate and evaluate the Quality department

Requirements:

• Bachelor’s degree in Engineering or related field
• 4+ years of relevant working experience in Quality in a manufacturing environment with 1+ year experience in a supervisory role
• Strong understanding of injection molding, Process Validation, Equipment Validation, IQ/OQ/PQ, Automation and FMEA
• Six sigma training and/or certifications preferred
• Ability to lift up to 30 lbs and stand, sit, walk 80% of the shift
• Excellent communication skill and intermediate statistical (SPC) knowledge
• Knowledge of PC applications such as Microsoft Word, Excel and Database software such as SAP
• Ability to travel between office and production departments

Preferred:

• Medical device and/or Pharmaceutical Industry experience

Work Environment:

• Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel.
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