DSJ Global
Senior Quality Assurance Specialist
DSJ Global, Atlanta, Georgia, United States, 30383
Senior Quality Assurance Specialist
Location:
Atlanta, GAWorking Situation:
HybridLevel:
Associate LevelJoin a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. The commitment to cutting-edge research and compassionate healthcare solutions ensures that every day brings new challenges and opportunities for growth. Be part of a team where your expertise and passion will drive impactful advancements in medical technology.
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
Senior Quality Assurance Specialist
our manufacturing site. The
Senior Quality Assurance Specialist
would be responsible for maintaining the Sterilization Facilities QMS requirements.
The Senior Quality Assurance Specialist 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 Senior Quality Assurance Specialist 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
If you are interested in the Senior Quality Assurance Specialist opportunity, apply now!
Location:
Atlanta, GAWorking Situation:
HybridLevel:
Associate LevelJoin a world leader in medical device innovation, transforming surgical care and improving patients' lives globally. The commitment to cutting-edge research and compassionate healthcare solutions ensures that every day brings new challenges and opportunities for growth. Be part of a team where your expertise and passion will drive impactful advancements in medical technology.
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
Senior Quality Assurance Specialist
our manufacturing site. The
Senior Quality Assurance Specialist
would be responsible for maintaining the Sterilization Facilities QMS requirements.
The Senior Quality Assurance Specialist 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 Senior Quality Assurance Specialist 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
If you are interested in the Senior Quality Assurance Specialist opportunity, apply now!