Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes. Our mission is to empower people living with diabetes through innovative solutions that simplify and improve their lives. We use our innovation and specialist expertise in diabetes to develop high quality solutions and tools that make a positive, daily difference for people with diabetes.
POSITION PURPOSE: This position provides quality assurance oversight of the product change control process and manages the documentation systems and processes for process validation, deviation management and reworks. The incumbent is responsible for the quality processes supporting development and maintenance of GxP software applications that support Quality System and business processes. The position is responsible for ensuring UDI implementations meet country requirements, including compliance timelines. Continuous improvement of processes through monitoring of Key Process Indicators (KPIs) and metrics is fundamental to the position.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Reviews product change documentation for accuracy, compliance to process and adherence to change control standards. Provides oversight of implementation of product changes to ensure accuracy and integrity of product configurations. Ensures change management processes align appropriately with 3rd party manufacturers and alliances. Resources are prioritized to support business requirements that include new product launches and product improvements. Measures of performance for product changes are developed and monitored to facilitate process improvements.
Manages staff, providing direction and growth/development opportunities.
Leads development and implementation of Quality System Projects which includes development of project proposals, project schedule and budget, software/system test plans and reports, and process validation plans and reports.
Manages the documentation system and processes supporting process validation, DMR deviations, rework processes and quality-related distribution deviations ensuring appropriate investigation and corrective and preventive action related to these areas.
Oversees UDI implementation to fulfill country requirements as rolled out globally, including establishing and maintaining interfaces between third party manufacturer production records, the UDI production database, customer complaint records and required country submissions.
Manages compliance of quality-related Material Master Data, globally.
Provides Quality oversight of the development and maintenance of GxP relevant software applications, ensuring the applications are compliant and are aligned with IT and business strategy/requirements. Provides support for Quality System applications to maintain configuration according to internal customer requirements. Develops and maintains software quality processes in accordance with global regulatory requirements.
Monitors performance of GxP applications and associated processes through development of metrics and KPIs to drive continuous improvement.
Bachelor's or Master's Degree in science, engineering, information systems, computer science, systems analysis or related field with minimum of 10 years relevant experience.
Strong understanding and skills in database administration and experience with electronic documentation/specification systems including ERP systems and Product Lifecycle Management/Change Management systems and Quality System applications.
Experience in Autodesk Fusion Lifecycle Management software and SharePoint applications is a plus.
Knowledge of quality system change management concepts required with experience in direct application of product Bill Of Material (BOM) structures and specification revision control.
Strong understanding of process validation, design verification/validation and deviation management
Understanding of FDA and ISO medical device regulations, specifically in the areas of Device Master Record maintenance, product change management, UDI and software lifecycle management required.
Keen attention to detail required.
Strong written and verbal communication skills are needed with the ability to clearly present information and describe quality documentation processes in controversial situations.
Strong interpersonal skills, including the ability to work with and influence individuals of diverse backgrounds and technical abilities.
Ability to supervise quality engineers and documentation specialists with a focus on personal development in addition to technical development.
Ability to make sound quality decisions under pressure.
Strong understanding of software and process validation.
Ability to manage inter and intra departmental projects that impact multiple sites and interface with cross-functional groups.
YOUR APPLICATION: Ascensia offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and are driven by innovation and the desire to improve the lives of our patients, we encourage you to apply now. Job postings will remain open for a minimum of five business days and are subject to immediate closure thereafter without additional notice.
TO ALL RECRUITMENT AGENCIES: Ascensia does not accept unsolicited third party resumes.
Ascensia is an Equal Opportunity Employer.
About Ascensia Diabetes Care
Ascensia Diabetes Care is a global specialist diabetes care company, dedicated to helping people living with diabetes.