Quality Assurance Officer - Liquids

Are you passionate about ensuring the highest standards of quality and compliance in the medical devices and pharmaceutical industries? Do you thrive in dynamic, fast-paced environments and enjoy taking on diverse responsibilities? If so, we have the perfect opportunity for you!

As a Quality Assurance Officer - Liquids, you will play a crucial role in ensuring compliance with established standards and regulations governing the manufacturing of medical devices and pharmaceutical products. You will contribute to maintaining and improving the company's quality system, working closely with various departments to support growth and quality compliance.

This is an exciting chance to be part of a small, collaborative team with a growing and diverse product portfolio. You will have the opportunity to shape and implement QA processes, while guiding the company toward continuous improvement in quality practices.

 Tasks & responsibilities:

Organisation wide:

• First point of contact for Quality Assurance
• Provide quality guidance towards our C(D)MO’s and customers
• 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 and risk-assessments
• Participate, if applicable responsible, for review and releases of liquids finished products and active Pharmaceutical Ingredients 
• Lead or participate in (quality improvement) projects
• Train staff on Quality Assurance aspects
• Review measurement and analysis (trend) reports with Quality Assurance relevance
• Supporting the organisation in internal-,external audits and inspections

In assigned organisational domains:

• Perform QA responsibilities
• Establish, develop, implement and maintain as-needed QA processes
• Participate in Change Controls, CAPA and complaint handling, review, approve and ensuring meeting timelines
• Regular (trend) reports and on-request reports
• Represent QA in multidisciplinary teams (e.g. Project Management, Regulatory and Business development)
• Represent QA in meeting with applicable stakeholders ( internal and external)

 Responsibilities:

• Taking an executive, supervisory and advisory position on some of the following areas of responsibility
• Management system & processes
• Sterility & sterilisation (Bioburden, Environmental monitoring)
• Managing, deviations, root cause investigations,,CAPA, complaints and changes
• Oversight on stability program
• Document and 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 and/or supplier audits

Skills and knowledge:

• At least in possession of Bsc working and thinking level
• High degree of independence and initiative
• Team worker
• Excellent communication skills and persuasiveness
• Organized and structured way of working, accurate
• Customer focused
• Computer skills, such as MS Office, Databases, and similar
• Preferably experience in auditing
• Experience and/or education in LEAN
• Preferably in possession of a technical (and preferably medical) educational background
• Relevant QA experience in the field of life-sciences
• Preferably 5 years of working experience in a similar position
• Excellent knowledge of the English 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 - Liquids?