Job Description

Job Purpose
QS&C Specialist work on two different areas of quality system. One is document management, and another is NCR/CAPA.
Document Management

• Management of documents, records and respective document management systems (DMS) applicable location: Straumann group, Straumann company, and Straumann Design Center.
• Ensure governance of document control and records management for documents lifecycle including review, distribution and change of documents according to standards and procedures.
• Coordinate implementation and update of document and records management system.

NCR/CAPA

• Actively participating in the NC & CAPA processes to ensure robust investigations, risk assessments, corrections and corrective / preventive actions are effective and completed in a timely manner.
• Ensuring KPI's are achieved, and processes are followed, evaluated, and improved.
• Extracting data, analyzing the data to conclude & propose appropriate action and present this along with the KPI performance on a monthly, bi-annual and annual basis through regular data review meetings and Management Review.

Main Tasks and Responsibilities (with key words)
Document management

• Review document attributes in the approval workflow
• Manage periodic review of QMS documents
• Manage permission / add and remove users into specific user group
• Ensure regular monitoring, updates and control of international standard changes
• Ensure completion of gap assessment for international standards and regulations.
• Support ETQ users and address their questions/requests.

NCR CAPA

• Tracks NC/CAPA activity for the Basel Design Center to ensure KPI's are achieved.
• Follow's up with NC/CAPA owners to ensure timelines are achieved and provide guidance where needed on key process steps e.g., root cause investigation, risk assessment etc.
• Ensures training material is current and delivers NC / CAPA system training & process training.
• Support NC & CAPA Manager in maintaining NC/CAPA procedures to ensure they provide the correct level of instruction and information to allow users to comply with the requirements specified.
• Support NC & CAPA Manager in prepare and lead the monthly NC/CAPA Data Review Boards to ensure actions are tracked and appropriate decisions taken based on the data provided.
• Support NC & CAPA Manager in preparing Management review data and conclusions as per the defined schedule.
• Coordinates the NC notifications from subsidiaries and distributors to ensure actions are addressed in a timely manner.

Requirements needed
Education

• Master's degree in a relevant field of work or an equivalent combination of education and work-related experience.

Experience

• Previous experience in quality management within the medical devices/pharmaceutical industry, in particular NCR & CAPA processing, document control, and external audit.
• Knowledge and understanding of applicable medical device regulations (ISO 13485, FDA QSR, MDR etc.)
• Knowledge/experience working with electronic documentation management systems (EDMS), and ERP (SAP mainly).

Personal Attributes

• Reliability and diligence, also when working under pressure
• Innovative, resourceful, and proactive disposition, committed to ensuring continuous improvement of capacity and delivering quality service
• Ability to communicate effectively with both internal and external personnel
• Adequate computer skills, including ability to work effectively with MS Office, in particular Excel and Word
• Fluent (written and spoken) English, preferably also German or French; any additional language an asset.