Quality Assurance Officer

As Quality Assurance Officer, you will ensure compliance with established legislation, standards and requirements applicable to manufacturers of medical devices and pharmaceutical products. Securing the company's quality system by implementing and improving QA processes and participating in, monitoring and supporting the improvement of quality system processes of all departments on assigned areas of responsibility.
 

Tasks & responsibilities:

Organisation wide:

  • First point of contact for Quality Assurance on the shop floor
  • Supervising execution according to quality system policies, processes and objectives
  • Monitoring non-QA processes by participating as an independent party and reporting or approving, specifically for process validation 
  • Train staff on Quality Assurance aspects
  • Review measurement and analysis (trend) reports with Quality Assurance relevance
  • Supporting the organisation in external audits and inspections
In assigned organisational domains:
  • Perform QA responsibilities
  • Establish, develop, implement and maintain as-needed QA processes
  • Support line managers in establishing, revising, implementing and controlling non-QA procedures
  • Monitoring progress according to project or programme plan
  • Regular (trend) reports and on-request reports
  • Setting up, conducting and administering training on Quality Assurance aspects
Responsibilities:
  • Taking an executive, supervisory and advisory position on some of the following areas of responsibility
  • Management system & processes
  • Validation & calibration (processes, products, infrastructure and equipment)
  • Work environment (Cleanroom, ESD, Laser)
  • Sterility & sterilisation (Bioburden, Environmental monitoring)
  • Deviation management & CAPA
  • Audit & inspection
  • Document of record control
  • Design & development reviews, including requirements review (also covering verifiability and validation)
  • Risk management (including biocompatibility and usability)
  • International quality standards & legislation
  • Monitoring process adherence to quality system processes
  • Planning and performing internal audits
Skills and knowledge:
  • Knowledge of ISO 13485, MDASP, 21CFR820
  • High degree of independence and initiative
  • Excellent communication skills and persuasiveness
  • Computer skills, such as MS Office, Databases, and similar
  • Computer skills in document control
  • Statistical methods of research; familiar with use of statistical packages (Minitab or similar)
  • Good skill is desired in handling a PC/terminal for consulting data and preparing documents
  • Preferably in possession of auditor certification
  • At least in possession of hbo working and thinking level
  • Preferably in possession of a technical (and preferably medical) educational background
  • Relevant QA experience in the field of medical devices
  • Preferably 5 years of working experience in a similar position
  • Excellent knowledge of the English language and good knowledge of the Dutch language.

Does DORC make you happy?    

Does working for you mean working together? Realising surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organisation where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC is the place for you.   

Would you like to know more about working at DORC? Then read on here. 

What does DORC have to offer you?  

At DORC, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:  

  • 27 holidays and 13 adv-days for a 40-hour full-time job 
  • 8% holiday pay  
  • 13th month
  • Bonus scheme
  • A travel allowance of € 0.23/km  
  • And a non-contributory pension, which means you will receive a substantially higher net salary   

What else can you expect from us? Every opportunity to learn and grow. Your own laptop and smartphone. And a fantastic company restaurant full of delicious, fresh products.  

Did you know ...?

DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.

DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.

Will you be our new Quality Assurance Officer?     

Are you up for this? Then apply directly via the red button! Do you still have questions? Then contact Monique Meiling our Global Recruiter: m.meiling@dorcglobal.com.
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