(Sterilization) Quality Engineer

Job Description:

• 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 sterilized to ensure compliance to regulatory, customer and internal standards.

Description of Work:

• This position interacts 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, assist with FMEAs and control plans, assist with documentation in 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 to 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 maintain compliance to the regulatory requirements of the FDA and ISO standards.
• Ensures compliance to 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.
• Drive improvements to deliver on key quality goals and metrics.
• Able to react to change and perform other duties as assigned.

Minimum Qualifications:

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

Skills/Experience:

• Strong knowledge of the regulatory and quality system requirements 21 CFR Parts 820, 210/211, ISO 9001, ISO 13485, ISO 11137 and ISO 11737.
• Leadership ability to coordinate projects at multiple locations in a multi-functional team environment.
• Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
• Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
• Good understanding of continuous improvement methodologies, including lean, six sigma, statistical applications and validation.
• Must have proficiency using Microsoft Office, Project, Outlook, and software applications.
• Demonstrated technical writing skills.
• Experience with sterilization processes highly preferred.
• ASQ Certified Quality Engineer desired.
• Minitab software proficiency, desired.
• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams.
• Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.
• Comfortable in giving direction to accomplish work being executed.