QA Officer at CAM Bioceramics B.V.
32-40 hours Leiden, start date as soon as possible
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. The environment is innovative, energetic and full of opportunity. Our company thrives on a diverse workforce.
We are looking for a highly motivated, talented and detailed QA Officer that thrives in a dynamic and changing production environment.
Our new colleague will play a fundamental role in achieving our growth ambitious and sales objectives. You will be responsible for maintaining and developing our quality system, i.e. ISO 13485, GMP. Besides, you will organize, plan and perform internal and external supplier audits, assist with NCR’s and CAPA’s and close out audit CAPA’s and reports. The QA Officer works closely with the other QA Officers (3), stakeholders in production, Engineering and in a team with the QC Officers (2) and RA Officer.
- To ensure that all work carried out in our site is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines;
- Maintaining and developing quality system i.e. ISO 13485, GMP;
- Organize, plan and perform internal and external supplier audits;
- Assist with NCR’s and CAPA’s and close out audit CAPA’s and reports;
- Monitoring and maintaining QA policies and procedures;
- Leading/supporting investigation of customer complaints and non-conformance issues;
- Recording and reporting quality data;
- Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality;
- Identify training needs and organize training interventions to meet quality standards;
- Identify non-compliance and support activity to address this with managers and teams;
- Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met;
- Provide first-line response to quality assurance interventions to emergency situations.
Our ideal candidate:
- Holds a Bachelor and/ or Master degree in a relevant field;
- Has five years relevant working experience;
- 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;
- Experience and understanding of CAPA, complaint handling, nonconforming product (NCR) process, document control, Device History Record (DHR) product release, and quality system structure;
- Experience in fast paced and detail oriented environment heavy with requirements for complete and accurate documentation;
- Understanding of good documentation practices;
- Ability to successfully multitask;
- Organized, with good communication skills, and attention to detail;
- Fluency in Dutch and English is required;
- Excellent communication and presentation skills;
- Focus on quality and detail;
- Careful planning to achieve accurate and timely results;
- Ability to define and manage own tasks and schedules;
- Team player, but resolute when needed, comfortable reporting to remote management;
- Comfortable making decisions within assigned authority, comfortable to escalate when needed;
- Able to train or mentor others that are new to quality system functions or practices;
- Quality systems internal auditor training or certification;
- Computer skills, Microsoft Office, Word, Excel, other as needed;
- Familiar with FMEA methodology.
If you think CAM Bioceramics B.V. is the company you are looking for, please send us your motivational letter and resume via email@example.com with reference “QA”. If you need more information about this position please contact our HR department via firstname.lastname@example.org or +31 71 524 0600. We hope to hear from you soon!