Quality Validation Engineer III

Responsibilities:

• Supports the manufacturing process owners and other functional area managers as a Quality Management System subject matter expert Leads complex cross-functional quality investigations in a variety of subject matter area to determine root cause and corrective actions.
• Develops improvements to the Quality Management System to enhance compliance with regulatory requirements.
• Leads teams to investigate deviations and non-conformances identifying root cause, corrective/preventive actions, and effectiveness of actions taken. Initiates, reviews and approves changes to procedures and processes to ensure compliance with required standards.
• Contributes expert process knowledge for product and process design and validation teams.
• Works directly with customers (internal, external, suppliers) on complex critical to quality issues. Leads cross-functional team projects (R&D, Mfg, Vendors, etc).
• Examples: support new product introduction projects or quality improvement projects.
• Performs complex statistical analysis to analyze trends, and supports site-level KPI metrics (e.g. yield improvements, CAPA, complaint, and scrap reduction)

Requirements:

• Bachelor's degree in engineering or Science Discipline.
• Minimum 5 years experience within the Medical Device or Pharmaceutical Industry supporting the manufacture of Regulated Product.
• Advanced knowledge of Quality Engineering principles and practices in a FDA Regulated Environment.
• Quality standards (e.g., 21 CFR Part 820, ISO 13485)Quality tools (e.g. FMEA, Risk Analysis, Root Cause Analysis) Computer Systems (e.g. Trackwise, AGILE, SAP).
• Proficient in team building and leading product quality investigations.
• Technical report documentation and authoring procedures. Resolution of Customer Complaints and CAPA

• Must Have: Quality, Validation, Analytical Instrument, Analytical Method, Process Validation
• 7+ years overall exp
• Preferred skills: Analytical Instrument experience, Analytical Method, Process Validation