Quality Assurance Officer Liquids

At DORC, your work directly impacts one of the most delicate and meaningful areas of medicine: restoring sight. As Quality Assurance Officer (Liquids), you hold a critical and senior position within the organisation, ensuring full compliance with stringent quality standards and regulatory requirements applicable to manufacturers of pharmaceutical products and medical devices. Your responsibilities are mainly focused on pharmaceuticals in regards of safeguarding, implementing and continuously improving the company’s quality management system, while acting as a trusted QA authority across the organisation and towards external partners. This role combines strategic oversight with a strong hands-on approach, requiring active involvement in daily QA activities and operational processes.
Working within a small, dedicated team and supporting a developing and increasingly diverse product portfolio, you operate with a high degree of independence, ownership and accountability. You actively contribute to organisational growth by embedding quality excellence into processes, decision-making and cross-departmental collaboration. 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, Changes, deviations, root cause investigations, CAPA, and complaints
• Document and record control
• Design & development reviews, including requirements review (also covering verifiability and validation)
• Post Market Surveillance, from QA -point of view
• 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, MS Teams, 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

Why DORC At DORC, innovation, quality, and technology are embedded in our DNA. You will work in an environment that combines high technical ambition with a pragmatic, hands-on culture. We value ownership, curiosity, and collaboration, and we give our engineers the freedom and responsibility to shape solutions that truly matter. DORC is proud of its multicultural working environment and actively attracts international talent. For outstanding candidates, visa sponsorship and relocation support are available. Would you like to know more about working at DORC? Then read on here. What We Offer 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 based on a 40-hour work week
• 8% holiday allowance
• 13th month salary
• Performance-based bonus scheme
• Travel allowance of €0.23 per kilometer
• Non-contributory pension plan resulting in a higher net salary
• Extensive opportunities for learning, development, and career growth
• A high-quality company restaurant offering fresh, healthy meals

About DORC DORC (Dutch Ophthalmic Research Center) develops and manufactures advanced equipment, instruments, and consumables used in eye surgery worldwide. 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 Anne Prins-Hooijmans, our Global Recruiter: anne.prins.ext@zeiss.com. An assessment or the request for a Certificate of Good Conduct (VOG) may be part of the selection process.