Engineering Human Resources Management & Business Others Medical and Healthcare Other Science and Tech
1 - 2 Years
(fulltime) Leiden, start date as soon as possible
We invite you to join a winning team that delivers products and services to industry leaders in the orthopedic, dental and aesthetic sectors.
Today we are hiring industry talents to support CAM Bioceramics achieving its future goals and remain the leading company in its field.
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 QA Officer.
As a QA Officer within a fast growing contract development and manufacturing organization you will be mainly responsible for the overall and cross-departmental processes related to Quality Assurance.
Main tasks and responsibilities:
Assessment of paper and electronic batch records for completeness, clarity and ISO 13485 compliance.
Responsible for designing, maintaining, safeguarding and optimizing the quality system.
Responsible for the timely approval of QA-verified documentation (SOPs, Batch Records, work instructions etc.).
Responsible for training (new) personnel. Maintaining training records for each employee and making sure that all personnel have received and finalized their training within a set timeframe.
Responsible for registering, investigating and reporting internal and external complaints.
Responsible for coordinating, conducting and/or supervising internal and external audits.
Initiate corrective and preventative measures (CAPAs).
Responsible for assessing change requests for consistency, relevance, ISO compliance and clarity.
Our ideal candidate has:
A minimum of Bachelor degree in Science or comparable level through experience;
At least 5 years relevant (international) experience in Quality Assurance preferably in a related field (medical devices, pharmacy);
Ability to define and manage own tasks and schedules;
Up to date knowledge of current ISO regulations.
You acknowledge and assume responsibility for performance of your results, demonstrate ownership, keep commitments, and have a positive attitude in a changing environment;
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.
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 email@example.com with reference QA Officer. If you need more information about this position please contact our HR department via firstname.lastname@example.org.