Ascensia Diabetes Care is a global diabetes care company, dedicated to helping improve the lives of people with diabetes by empowering them to take charge of their health. At Ascensia, we want to serve the needs of patients through our innovation and specialist expertise in diabetes. We create high quality solutions and precision tools that help patients manage their condition. Innovation is in our DNA and we are agile, entrepreneurial and dynamic in the way we operate.
The challenging and rewarding position of Project Quality Management at Ascensia requires both Project Management and Quality Assurance knowledge and expertise. This position is part of every project management process from the moment the project initiates to the final steps in the project's final phase.
The incumbent in this role must ensure that all project activities necessary to design, plan, implement and launch a project are effective and efficient with respect to its purpose and objectives.
The Project Quality Management Lead, as a member of multi-functional Global Program Teams, represents this essential component of Ascensia’s New Product Development process.
MAJOR TASKS AND RESPONSIBILITIES OF POSITION:
Represents the Quality Management function on Global Program Teams
Leads a support a team of Quality related subject matter experts
Accountable and responsible for Project Planning, Driving Project Progress and Implementing Project Quality Assurance Objectives and Deliverables
Mentor/Guide/Role Model of Project Quality Assurance Objectives to the Global Program Team
Ensures applicable Quality System processes are considered and utilized appropriately during New Product Development; Planning, Design Control, Risk Management, Training, etc.
Supports and Guides the Global Program Team’s efforts leading up to and during required Technical and Business reviews
Ensures, project status is appropriately communicated to Senior Management within the Quality Organization
Decision Making and Problem Resolution:
Represents the Quality Function regarding decisions and deliverables
Supports/drives understanding of proper impact/risk analysis techniques during this process
Identifies perceived issues and communicates rationale with clarity and suggested solution(s) when possible
Manages project issues in an orderly manner and tracks to an appropriate conclusion in an effective and timely manner
Where appropriate, effectively facilitates and participates to a meaningful result, discussions or debates that arise during the project.
Always communicates with clarity and at an appropriate level and degree of complexity given the customer’s or stakeholder’s position and needs
Understands how/who to communicate commensurate with associated risk
Communicate risk management best practice
Delivers periodic, concise program updates to Senior Management
Works closely with Global Quality functional leadership to ensure their awareness of your projects and resource needs
Serve as a primary interface for internal and external audits
Ensure Product Development Process is followed
Ensure proper documentation practices
Ensure Project and Product risks are identified, communicated and properly documented in a timely manner
Identify/Initiate assessment/action of quality issues/opportunities
Support preparation of documentation required for internal/3rd party audits
Manage project relevant budgets and resources
BS degree in a Technical or Life Science area - i.e. Biology or Chemistry, Engineering, Computer Science, Computer Technology
8+ years of experience in Product Development
Proven, experience with New Product Development
Proven experience with Project Management
Proven experience as a Team Lead
Experience with Medical Device Development
Familiarity operating under the Guidance of 21 CFR Part 820 and the ISO 13485 Standard
Knowledge of ISO 14971
Strong communication, writing and negotiating skills
Works well in cross-functional, multi-site (including offshore) teams.
Familiarity with Glucose Monitoring devices
Familiarity with Software Development practices
Experience working in an environment that follows a structured development process model.
Experience with Regulatory Body procedures, processes, and/or audits
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.