Katalyst Healthcares and Life Sciences
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.
- 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.
- 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.
- 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.