Principal Quality Assurance Sterilization Engineer
Careers that Change Lives
In this exciting role as a Principal Quality Assurance Sterilization Engineer you will have responsibility for leadership, support and oversight to the biological safety (biocompatibility) requirements for HeartWare products and the site’s Sterility Assurance (SA) programs which include Traffic & Gowning, Cleaning & Disinfection, Environmental Monitoring (EM), Utilities monitoring, and Terminal Sterilization Processes provided by external contractors.
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
Manages Sterility Assurance program including planning and execution of all required sterilization validation work in support of manufacturing and new product development activities in accordance with internationally recognized sterilization standards.
Development, qualification, maintenance, and non-conformance analysis of an annual testing program for ensuring that EO sterilized devices meet compliance requirements for EO and ECH residuals in accordance with international standards.
Provides technical evaluation strategies and solutions to product development and manufacturing in the area of biocompatibility.
Assists in the preparation and response to regulatory submissions on sterilization and biocompatibility topics.
Oversees routine and surveillance EM and Utilities monitoring activities in Operations.
Continually analyzes environmental and/or utility monitoring data from the manufacturing areas for purposes of remediation of any developing trends.
Develops and manages continuous improvement actions and projects in order to reduce EM excursions, as well as improving aspects related to cost, safety, and productivity in any of the SA programs.
Ensures adherence of manufacturing activities to program requirements and regulatory expectations.
Ensures quality of product through observation/auditing, investigations, training and management of procedures.
SA objectives are achieved through this position’s active involvement and leadership in SA / EM related deviations, procedure revisions, training programs, CAPA and Change control management systems, as well as through informal and formal auditing. In addition, this position helps ensure operations understanding of SA program through meetings and other means of communication.
This position includes interaction with regulatory agency inspectors, as well as ensuring that the site’s SA programs and staff remain in an inspection-ready state. This includes promptly addressing any agency concerns and compliance gaps.
This position will perform special projects as assigned as well as review relevant regulatory guidance in order to identify gaps within site programs and develop remediation strategy with functional leads.
Review change request documents.
Ensure compliance to HeartWare Design Control Standard Practices, software validation, process validations and test method validation procedures with regards to sterility assurance processes.
Ensure that project and process development documentation are compliant with requirements and objectives. Review design, change specifications, and plan against process requirements.
Lead investigation on CAPA’s as it relates to the assigned area of support.
Ensures compliance to all customers, QSR, cGMP, ISO 13485 and Medical Device Directive requirements.Leads the group in performing risk analysis, root cause analysis of non-conforming product, in concert with other departments.
Identifies and recommends corrective and preventive actions resulting from product evaluation activities.
Ensures proper documentation of product field failures investigations to meet regulatory requirements and support non-conformance trending.Publishes QA reports of Quality activities per required frequency.
Conducts quality system audits as required per schedule.
Provides Quality related training/education for company personnel.
Reviews and approve updates needed to product specifications.
Must Have: Minimum Requirements
Bachelor's degree in engineering, science, or technical discipline with 7+ years experience in support of sterility assurance programs in medical device industry.
OR Master's degree in engineering, science, or technical discipline with 5+ years experience in support of sterility assurance programs in medical device industry.
Nice to Have
Bachelor’s Degree in Engineering, Microbiology, Chemistry, or a related degree with scientific, engineering, clinical or regulatory course of study optimal. BS in microbiology strongly preferred.
Demonstrated experience with EN ISO 11135 Medical devices – Validation and routine control of ethylene oxide sterilization, ISO 11607 Packaging for terminally sterilized medical devices, EN ISO 10993 FDA QSR/21 CFR Part 820, ISO 14971 and ISO 13485.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.