Manager QA/QC/RA at CAM Bioceramics
fulltime / part time (32-40 hours) Leiden, start a.s.a.p.
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.
As a Manager QA/QC/RA you are committed to, through dedication to quality and continuous improvement, providing customer satisfaction by meeting customer requirements, maintaining the effectiveness of the CAM Quality management system and complying with requirements of applicable standards and regulations. You will be a member of the Management Team at CAM.
Main tasks and responsibilities:
- Maintain the effectiveness the CAM Quality Management System;
- Implement and assure CAM’s compliance with applicable rules and regulations (ISO 13485, relevant cGMP, Dekra FDA);
- Deliver quality input for Management reviews;
- Engaged with the functional Management team to maintain alignment and support for Quality activities
- Inform Management Team of significant deviations and complaints
- Revise procedures to inspect and report quality issues;
- Monitor and manage operations that affect quality;
- Successfully coordinates audits and guide inspectors, technicians and other staff during audits;
- Assure the reliability and consistency of production by checking processes and final output;
- Appraise quality requirements and make sure they are fulfilled;
- Report all malfunctions to production executives to ensure immediate action;
- Facilitate proactive solutions to process owners by collecting and analysing quality data;
- Review current standards and policies and report on it and/or inform Management Team;
- Keep records of quality reports, statistical reviews and relevant documentation;
- Ensure all legislations and regulations standards are met;
- Communicate with external quality assurance officers during on-site inspections;
- Ensure CAM successfully passes (customer or third party) audits
- Manage, develop and motivate a team of QA Officers and QC laboratory.
- Budget responsibility
Our ideal candidate has:
- Master’s degree relevant to the position in quality management;
- Successful track record as manager in QA/QC/RA or similar role;
- Minimum of 10 years relevant working experience;
- Knowledge of quality systems and techniques ie.: ISO 13485, GMP, MEDDEV, FDA;
- Knowledge of applicable rules and regulations in the field of Medical Devices and or Drugs
- Outstanding coaching, communication and leadership skills;
- You are highly motivated, driven by results and quality
- You acknowledge and assume responsibility for performance of your results, demonstrate ownership, keep commitments, and have a positive attitude in a changing environment;
- Comfortable making decisions within assigned authority, comfortable to escalate when needed, also in high pressure situations (stress resilient)
- Service oriented team player;
- Fluent in Dutch and English;
- Working knowledge of budgets, forecasting and metrics.
- Ability to effectively communicate at all levels of the organisation;
- Excellent audit and presentation skills
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 firstname.lastname@example.org with reference “Manager QA/QC/RA” before the 18th of October 2019. If you need more information about this position please contact our HR department via email@example.com or +31 71 524 0600.
Acquisitie n.a.v. deze advertentie wordt niet op prijs gesteld, we hebben een recruitment partner die ons ondersteunt in het werving & selectie proces.