Senior Quality Assurance Specialist - Alphen aan den Rijn
Alphen aan den Rijn, Zuid-Holland, NetherlandsQuality Assurance
When it comes to diagnosing cancer, there’s no time to waste!
At Sakura, we’re driven by our desire to advance cancer diagnosis through fully automated anatomic pathology and by providing our partners & patients with best-in-class innovations, quality and customer care.
What we do:
We empower pathology professionals all over the world by providing integrated solutions to deliver accurate & fast diagnoses of cancer, to optimize treatment success for each life we touch!
We're seeking an experienced quality assurance specialist who will take responsibility of the overall compliance of Sakura Finetek Europe Quality Management System to the relevant ISO standards, while promoting a collaborative atmosphere of quality awareness and continuous improvement.
You report directly to the Manager RA&QA EMEAI.
- Maintain and improve Quality Management System (QMS) according to the relevant ISO standards.
- Draft quality assurance policies and procedures.
- Evaluate adequacy the quality assurance standards.
- Conduct and monitor internal and external supplier audits.
- Support on-site audits conducted by external providers.
- Perform Internal Audits & process audits at Regional Business Units.
- Investigate customer complaints and non-conformance issues.
- Approve release of (reworked) products.
- Collect and compile statistical quality data.
- Analyse data to identify areas for improvement in the quality system.
- Recommend, develop and monitor corrective and preventive actions.
- Prepare reports to communicate outcomes of quality activities.
- Identify training needs and organize training interventions to meet quality standards.
- Evaluate audit findings and implement appropriate corrective actions.
- Realization of the personal targets, formulated in the cockpit.
- Realization of the team goals, formulated in the department plan.
We perfectly match if
- a bachelor's degree.
- certifications as Quality Auditor, Quality Engineer, Quality Improvement Associate or Six Sigma are preferred.
- proven working experience in an international technical area- medical devices is a plus.
- at least 5 years of experience with ISO 13485.
- quality inspection, auditing and testing experience.
- experience with implementation of corrective action programs.
- knowledge of tools, concepts and methodologies of QA.
- have a good command of English & preferably Dutch.
- have a strong presentation, negotiation & communication skills.
- IT skills including Microsoft Office, QA applications and databases.
- connect easily & make an impact at all levels.
- are self-organised, structured and independent.
- have a pragmatic can-do attitude.
We offer you:
- an attractive salary package, including 8% holiday pay, a yearly bonus of max. 8%, a fully paid pension plan (according to the Dutch low), 29 paid holidays (full-time), hybrid working, laptop, a daily freshly prepared lunch and a gym discount.
- a great international collaborative work environment.
and last but not least, a great job opportunity where you have full ownership of your work, recognition of your achievements and professional development opportunities.
Our culture is friendly and open. We believe that the development of our people enables the company's growth.
Apply today & join:
- an inspiring community with a mission that matters! ''advancing cancer diagnostics''.
- our International organization who's leaded by a supportive & inspiring management.
- a financial healthy & privately owned company.