Design Quality Assurance Product Center Manager

5 mesi fa

Palazzo Pignano, Italia Fresenius Medical Care A tempo pieno

Quality Business Partner to product Value Streams to ensure complaint products, engineering teams are supported with a value-added mindset, and Post Market Surveillance activities are performed, and actions derived.

Tasks performed regularly which form the essential characteristics of the position.

**Design Control**:

- Works as part of product development team on new product development or on design changes to ensure product quality and reliability, minimize risk to users and patients as well as regulatory and corporate SOP compliance.
- Reviews and approves design control deliverables along the product development process as well as design changes
- Reviews and approves Technical Reviews, Design Reviews and Phase Exit Reviews
- Reviews and approves Design and Technology Transfer Deliverables
- Guides engineering teams through the product development and design change process in a compliant and efficient way
- Creates quality plans and deviation notices if deemed necessary
- Provides training on Design & Development relevant quality requirements
- Review and Approval of Detailed Impact Assessments for Level 2 Design Changes. In addition, responsible of the definition, monitoring and closure of Risk Management activities.

**Product Conformity**:

- Main contact for medical device PD-Accessories marked with the CE-mark.
- Meeting the essential requirements for the CE declaration of conformity
- Checking CE conformity annually
- Ensuring technical file complete and up-to-date
- Submitting the declaration of conformity
- Initiating, supporting and releasing design changes (product safety change)
- Providing support during creation and maintenance of the clinical evaluation
- Responsible for the List of Standards

**Post Market Surveillance**
- Manage Post Market Surveillance activities
- Analyze PMS data collected and initiate the required activities.
- Detect and report trends

**NC/CAPA**
- Acts as a Quality Approver for design control related topics
- Acts as a Quality Assignee for system related topics

**Monitoring and Continuous Improvement**:

- Defines and tracks quality KPIs for continuous improvements and provides quality performance and trending to Vertical
- Drives continuous improvement in the area of quality processes, tools and methods in close alignment with the central SysQaRa unit
- Prepares and conducts regular quality review meetings
- Provides input to Management Reviews
- Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position.

**Representation of Risk Manager**:

- Risk management throughout the complete product life cycle
- Creating risk assessments with the support of the Risk Management Responsible
- Assessing potential product risks (from market observation and quality problems)
- ** Audit**:

- Facilitates internal and external audits for Home
- Acts as an auditee for relevant chapters

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