Quality Engineer

Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program. This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities. This position works closely with other functions within the organization (Manufacturing, Laboratory, R&D, Quality Systems, Engineering, Procurement, and Marketing) and is responsible for ensuring the sterilization requirements are met for product sterilization to ensure compliance with regulatory, customer, and internal standards.

Responsibilities:

• Interact with multiple functional groups within manufacturing and sterilization networks.
• Supports product sterility assurance and compliance across multiple sites within the Life Sciences division.
• Serves as the quality representative to support multiple projects within the division.
• Schedules/coordinates/performs assigned projects, compiles test data, writes summary reports, and final reports.
• Provides validation support, including master validation planning, change controls, protocol development, review and approvals, IQ/OQ/PQ execution/support, assists with FMEAs and control plans, and assists with documentation in the electronic document management system.
• Lead and support activities related to product changes impacting sterilization equipment/processes and the associated laboratory/functional testing required as part of the validations.
• Facilitate/support investigations for product and process discrepancies and propose corrective actions for process deviations and customer complaints.
• Assist with the investigation of Corrective & Preventive Actions (CAPA), providing solutions where possible.
• Create or modify user documentations that fit the business needs and maintains compliance with the regulatory requirements of the FDA and ISO standards.
• Ensures compliance with regulatory requirements related to product sterility assurance, including annual product reviews, environmental controls, bioburden testing, dose audit maintenance, and sterility testing.
• Serve as a resource for performing internal audits to ensure quality system compliance.quality engineering
• Drive improvements to deliver on key quality goals and metrics.
• Able to react to change and perform other duties as assigned.

Required Qualifications:

• Bachelor's Degree required, prefer program in the Sciences or Engineering.
• Minimum of 2+ years of  experience in a highly regulated industry; strongly prefer medical device or pharmaceutical.
• Direct experience in sterility assurance or product sterilization is a plus