Quality Operator

**Section 1: PURPOSE OF THE JOB**
- (Briefly summarize in 1 or 2 sentences what the position is designed to accomplish)_

Support QA related process in the distribution center: incoming inspection, returns, quarantine shipments, ship holds, printing of IFU’s, DHR reviews etc. in compliance with Abbott Quality system and ISO 13485.

**Section 2**:ROLES & RESPONSIBILITIES**
- (Make a list using action words to describe the roles and indicate the level of decision making)_

Against the background of the EMEAC QA system the following tasks will be performed according to SOPs and working instructions:

- Execute and follow-up on incoming and in process inspection (conducting visual inspections and rejecting non-compliant materials), returns, ship holds, quarantine shipments; document actions by completing reports and logs in the foreseen dbases
- Maintain Demo, SUBD, expired stock, Biohazard materials
- Ensure proper storage/labeling of all material requiring physical segregation: ship holds, quarantine, clinical trial products, products pending sterilization results, etc.
- Assist with internal audits
- Provide support in critical distribution activities including but not limited to labeling, packaging, shelf life extension, demo creation, scrap, service & repair, manufacturing activities (DHR review).
- Create high quality awareness in the EDC
- Updates job knowledge by participating in educational opportunities

**Responsibilities for all **functions**:

- This job description is intended to describe the general nature and level of the work being performed by people assigned to this work. This is not an exhaustive list of all duties and responsibilities.
- When tasks and responsibilities are assigned outside the scope of normal duties, the employee must understand the level of decision making for which he/she is responsible and if in doubt clarify this with his/her supervisor.

**Section 3: EDUCATION & COMPETENCIES**

School or University qualifications
- High school level
- Minimum of 2 years of experience in a similar position

Knowledge and skills (e.g. languages, PC,)
- Computer and ERP literate (Microsoft Office and SAP)
- Preferably knowledge of ISO 9000, ISO 13485
- Fluent in Dutch, English. Any other European language is a plus

Natural abilities (team player, stress resistant, discretion, good communicator, etc.)
- Team player
- Stress resistant, working to tight deadlines
- Accurate and disciplined
- Analytical
- Independent
- Process driven
- Quality minded
- Good communication and documentation skills

**Section 4: BACK UP**
- (Indicate another position that can take over the main tasks and responsibilities during the employee’s absence)_
- Quality Operations
- Quality Specialist
- Sr. Quality Specialist
- Quality Operations Manager EDC