QA officer

We are a dynamic and fast‑growing manufacturer in the medical device/pharma industry seeking an experienced and driven Quality Assurance Officer to strengthen our QA team.

CAM Bioceramics manufactures calcium phosphate ceramic materials used in Medical Devices and Excipients. We operate under ISO 13485 and GMP, with a strong focus on operational excellence and robust quality processes. We are looking for a proactive QA professional with a keen eye for detail who can confidently take ownership within key quality domains.

What you will be doing:

• Perform detailed batch record reviews to ensure completeness, accuracy, and compliance with regulatory requirements (e.g., ISO 13485)

• Manage document lifecycle and periodic review program

• Conduct detailed compliance review against SOPs and specifications

• Evaluate deviations (NCR/DP) impacting batch release

• Lead minor-to-moderate investigations (root cause analysis)

• Define and implement CAPAs

• Participate in risk assessments (FMEA)

• Assess documentation impact of change

• Conduct internal audits, assist in audits

• Support supplier qualification activities, review supplier deviations and change notifications

• Verify ALCOA+ principles during review

• Deliver SOP training to operational staff

• Provide quality input to management review

• Analyse trends and escalate risks

Ideal candidate Profile:

• Bachelor’s degree in Life Sciences, Engineering, or a related field (or equivalent work experience)

• 2 years of relevant experience as a QA Officer in a regulated environment

• Strong understanding of GMP and/or ISO 13485

• Sharp attention to detail and strong documentation skills

• Excellent analytical capability and problem-solving skills

• Good written and verbal communication skills

A collaborative team player who can also work independently and take ownership of assigned responsibilities

What we offer:

• An annual salary in the range of 40 to 45k€.

• 27 holidays (216 hours) based on a fulltime contract

• 8% holiday pay, to be paid out in May of each year

• 4% (of your annual salary) Individual Choice Budget to choose for additional holidays, sport allowance, a bicycle or to be paid gross whenever you choose throughout the calendar year.

• A dynamic and supportive workplace with growth opportunities.

• Exposure to cutting-edge manufacturing processes in the medical device field.

• Comprehensive training and onboarding

• A job in a cross-function team within a close-knit, and very ambitious company

• The freedom and space for your own ideas and the opportunity to develop and implement them yourself.

• An informal and inspiring workplace on the bioscience park in Leiden.

• Fast-growing organization where you can make a difference

• Cake: we love to celebrate successes together!

Interested?

If this sounds like your ideal challenge, or if you have questions about the position, please contact our Human Resources department at: careers@cambioceramics.com.

To apply, please submit your resume along with a short motivation letter explaining why you are interested in this role.