Quality Assurance Specialist II

Location: Greenville/Spartanburg/Anderson Area, SC

Working Situation: Onsite

Level: Associate Level

Our client is a global medical device company who is the industry leader of new product development. Our innovative company is actively searching for a new Quality Assurance Specialist II for our manufacturing site. The Quality Assurance Specialist II would be responsible for maintaining the Sterilization Facilities QMS requirements.

The Quality Assurance Specialist II will be responsible for:

• Ensure timely and accurate completion of sterile load files for our products.
• Oversee the Sterile Release program for produced loads, ensuring safe and prompt product release to meet customer demands.
• Address Non-Conformances observed during sterilization processes for the facility, including opening, evaluating, and closing such cases to resolve affected loads.
• Collaborate with Sterilization Facility Personnel to investigate Non-Conformances, identifying root causes and implementing preventive measures.
• Support process improvement initiatives within the Sterilization Facility program.
• Maintain procedures pertaining to Quality Assurance – Sterilization department activities, including reviewing related procedures and records.
• Serve as a lead auditor and/or subject matter expert for quality management system audits of sterilization service providers, in compliance with relevant standards such as ISO 13485, ISO 11135, and ISO 11137.
• Develop and execute protocols for sterilization processes and equipment validation/re-validation, including generating comprehensive reports and conclusions.
• Coordinate all activities related to sterilization validations and testing, liaising with external and corporate laboratories, as well as sterilizer personnel.
• Evaluate device compatibility with various sterilization modalities, ensuring adherence to applicable ISO requirements through microbiological and sterilization theory and practice.
• Collaborate effectively within cross-functional teams, serving as both a champion and team member.
• Support business objectives and expansion plans.
• Willingness to travel domestically and internationally, up to 10% of the time.

The Quality Assurance Specialist II will have the following qualifications:

• Bachelor's degree in Engineering, Biology/Microbiology, Chemistry, Toxicology, or related scientific field.
• Minimum of 2 years of relevant experience.
• Experience with Sterilization Processes (Ethylene Oxide (EO), Gamma, X-Ray

Knowledge and skills of the successful Quality Assurance Specialist II:

• Familiarity with FDA and ISO guidelines for medical device sterilization modalities.
• Understanding of manufacturing processes is advantageous.
• Preferably trained in project management and communication skills.
• Working knowledge of sterilization test systems requirements.
• Hands-on experience in managing sterilization product assessments and validations.
• Proficiency in writing test protocols and reports.
• Knowledge of ISO 13485 guidelines and principles of quality requirements.