QA Documentation Reviewer

We are a dynamic manufacturer in the field of medical devices seeking a detail-oriented and highly motivated Quality Documentation Reviewer to join our QA team. This is an excellent opportunity for someone with a passion for quality, compliance, and continuous improvement, ideally with a technical, scientific or administrative background and an eagerness to grow within the medical device industry.

CAM Bioceramics is a manufacturer of Calcium Phosphate ceramic materials used as components in Medical Devices and Excipients. It is an energetic environment operating under ISO13485 and GMP. The current QA team, composed of 4 members, ensures compliance and excellence of our internal processes. We are looking for a new member, possibly at an entry level, proactive and with a high level of attention to details.

What do we offer?

• An annual salary tailored to your experience

• 27 public holidays (216 hours) per year on a full-time contract

• 8% holiday allowance (paid in May)

• 4% Individual Choice Budget (e.g. extra leave, sports allowance, bicycle plan or payment)

• Comprehensive onboarding and training for entry as QA professional

• A challenging role in an international company, within a dynamic and diverse team

• A culture that values ownership and initiative

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

• A supportive and ambitious team that works together to achieve goals, sees challenges as opportunities

• An inspiring and informal workplace at the Leiden Bio Science Park

• The opportunity to contribute to the health and well-being of people worldwide

• Freedom to contribute your own ideas and initiatives, with opportunities to develop and implement them

• Fast-growing organization where you can make a difference

• Cake: we love to celebrate successes together!

Key responsibilities:

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

• Identify and escalate any discrepancies or deviations in production records.

• Collaborate with Production, Quality Control, and Regulatory Affairs to resolve documentation issues.

• Support QA documentation processes including filing, archiving, and audit preparation.

• Assist in the development and continuous improvement of QA processes and SOPs.

• Monitoring and maintaining QMS controlled documents (inform owners about periodic review).

• Recording and reporting quality data, provide input for management.

  Who are you?

• Strong attention to detail — spotting inconsistencies and documentation gaps is second nature to you.

• Comfortable working in a highly regulated environment with a structured and organized approach.

• Some experience in a GMP or ISO 13485-regulated setting is a plus, but not required.

• Analytical mindset with good written and verbal communication skills.

• A collaborative team player who can also work independently when needed.

• Bachelor’s degree in Life Sciences, Engineering, or a related field preferred, or equivalent work experience as an administrative officer.

Interested?

If this sounds like the ideal, maybe first of a different, step in your career, or if you would like to ask a question, please reach out to our HR-department at Careers@cambioceramics.com.