QA Manager Healthcare
il y a 1 mois
Barco designs technology that makes everyday life a little better. Seeing beyond the image, we develop sight, sound, and sharing solutions to help you work together, share insights, and wow audiences. Our focus is on three core markets: Enterprise (from meeting and control rooms to corporate spaces), Healthcare (from the radiology department to the operating room), and Entertainment (from movie theaters to live events and attractions). Our solutions make a visible impact, allowing people to enjoy compelling entertainment experiences; to foster knowledge sharing and smart decision-making in organizations and to help hospitals provide their patients with the best possible healthcare. Headquartered in Kortrijk (Belgium), Barco realized sales of 804 million euro in 2021 and has a global team of 3,000+ employees, whose passion for technology is captured in +500 granted patents.
Is Quality your motto? Do you want to collaborate with various departments to maintain a strong quality process and quality standard?
Within our site we are looking for a Quality Manager to join our team
The ISO9001-ISO 13485-ISO14001 quality management systems of Barco, ensuring the systems meet the need of the business and comply with all the applicable standards and regulations
Your responsibilities:
- Maintains and continuously improves the division quality management system in line with the business needs and compliant with the required standards and regulations for that region and/or division.
- Plans, coordinates and conducts external certification, customer audits and internal audits. Calls for the required corrective actions, monitors the progress and escalates deviations to higher management.
- Facilitates improvements and corrective actions (CAPA) with main focus on product corrective action process. Proposes, supports or leads improvement initiatives (short/mid-term) for processes and practices.
- Identify training needs and organize training interventions to meet quality standards and maintain own training matrix
- Participates in NPI projects as Quality delegate and acts as Quality gatekeeper in NPI stage gate review meetings
- Reports process / product performance figures, deviations, progress on quality performance or the need for improvement and changes in line with the divisional quality plan and objectives (e.g. inputs from customer surveys, field info, …)
- Has the authority to
- withdraw non-conforming products
- set / release production or delivery holds
- sign off CoCs (beyond CoC of manufactured products) and derogations
- Coordinates customer escalations and requested QA meetings
- Executes internal audits against QMS requirements
- Agile software development
- Collaborate with product owner in roadmap planning, sprint planning, sprint reviews to understand and prioritize issues, risks and opportunities
- Provide inputs serving software release decisions, ensuring verification and validation activities are carried out by the software teams before release
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- Ensures the promotion of awareness of applicable regulatory and QMS requirements throughout the organization
- Reports on the performance, effectiveness and improvement needs of the QMS to top management
- Ensures the documentation of the processes needed for the QMS
- Execute Quality Assurance responsibilities in medical devices risk management process and review technical documentation on sample basis
Your Profile:
- At least 7 years of experience in QA\QMS management and at least 3 years in a leadership role.
- Profound understanding of QMS, ISO requirements (ISO9001, ISO13485, ISO14971, IEC62304, IEC62366,...) and regulatory to maintain business quality certifications
- Certification training for quality management systems internal auditor and experience in internal auditing against QMS
- Experience in coordination of external audits (certification bodies, customers, local authorities)
- Excellent verbal and written communication skills, listening skills and able to cope with stressful situations
- Solution directed and E2E continuous improvement attitude.
- Sound judgment and high level of integrity and ethics
- Excellent leadership and organizational skills; demonstrated ability to motivate others, work as a team and take ownership where required.
- Excellent tactical and strategic thinking
- Analytical, investigative and decision-making skills
- Ability to deal with and manage a diverse and demanding workload
Our offer:
- A competitive salary package with fringe benefits such as a health and group insurance, canteen, bonus perfomance system...
- An interesting, challenging job with lots of autonomy.
- The opportunity to work for an international market leader where innovation does matter.
- Internal training in our Barco University
- A modern and state of the art working environment
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