CAM Bioceramics B.V. is the global number one manufacturer of choice for our partners who are looking for the highest quality and best service in the field of Orthobiologic Ceramics. We are working with the leading companies in the medical & dental (device) industries, start-ups with compelling business ideas and engaged universities. We co-op with our customers in the United States, Europe, Asia and in Emerging Markets. We will continue to seek and deploy technological and engineering advancements. If you’re passionate about your field, we have a wide array of positions available at our HQ in Leiden. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce. Due to growth in our company we are looking for a QC Specialist.

As an QC specialist within a fast growing contract development and manufacturing organization you will be mainly responsible for timely and according to specifications efficiently perform analysis, process and input controls.

Also, the support of the other departments in the field of all QC-related matters and advising relevant stakeholders is part of your job. You will review incoming goods, documentation regarding product specifications, verifications, and validation. To manage and perform validation activities in support of the QC/QA organization. These activities consist of developing and authoring validation protocols and reports, authoring analytical methods, analytical method transfers and development of methods. Strong knowledge of Analytical chemistry or biochemistry validation in order to be a subject matter expert during audits and technical troubleshooting in QC laboratories.

Main tasks and responsibilities:

• Timely, and according to specifications efficiently perform analysis, process and input controls;
• Act as Subject matter expert for audits and internal investigations;
• Planning and tracking of validation/transfer/development activities according to schedule
• Author/own QC methods and specifications;
• Perform analytical method validation and maintain validation status;
• Train and mentor junior level staff in QC analysis;
• Coordinate and plan day to day QC validation activities with QC Testing management to agreed upon schedule;
• Provide QA oversight and/or review during the validation process for QC Analytical lab equipment and methods;
• Perform compliance reviews of Validation Protocols and Final Reports in support of validation efforts;
• Develop and revise applicable SOPs and provides compliance oversight and support to the QC department upon request;
• Perform compliance reviews of change control requests; deviations, investigations, and CAPAs related to qualification and validation;
• Review project, validation and change control documentation for the site’s QMS (Document Management/Compliance Modules) to assure compliance;
• Issues the relevant Quality Records and, when necessary, write and send to Manager QA/QC/RA non-conformances reports;
• Support laboratory investigations for known lab errors and OOS results and/or other QC procedures;
• Other duties may include support to the Engineering Team in evaluating all tests needed to qualify critical equipment, utilities, and processes;
• Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written;
• Maintain the effectiveness of the position related processes of the Quality System.

Our ideal candidate has:

• A minimum of Bachelor degree in Science or comparable level through experience;
• At least 5 years relevant (international) experience Quality Control in a laboratory or production department (e.g. as a laboratory analyst or process engineer) preferably in a related field (medical devices, pharmacy);
• Experience in a structured quality system environment (such as ISO 9001, ISO 13485, FDA part 820, FDA Part 210/211 or other), working in a Quality Department, preferably in a medical device environment;
• Knowledge of 21 CFR Part 820 and/or 21 CFR Part 210/211;
• Experience with process validation including generating protocols, test scripts and writing final reports is strongly desired;
• Familiar with FMEA methodology.
• Comfortable making decisions within the assigned authority, comfortable to escalate when needed;
• You are highly motivated, quality driven and a team player;
• Good knowledge of Dutch and English (verbal and written);
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Experience in an ISO 13485 environment is necessary.

Interested?

If you think CAM Bioceramics B.V. may be a great fit for the next step in your career, please send us your motivational letter and resume via careers@cambioceramics.com with reference QC Specialist. If you need more information about this position please contact our HR department via hr@cambioceramics.com.