QA Documentation Reviewer (FT)

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.

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.

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?

Our ideal candidate profile:

·         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.

What do we offer?

Ø     An annual salary tailored to your experience

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

Ø     8% holiday allowance (paid in May)

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

Ø     Comprehensive onboarding and training for entry as QA professional

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

Ø     A culture that values ownership and initiative

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

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

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

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

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

Ø     Fast-growing organization where you can make a difference

Ø     Cake: we love to celebrate successes together!