Quality Management System Specialist
Quality Management System Specialist
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1 Vacancy
Job Description
Topcon Healthcare is seeking a highly motivated Quality Management System (QMS) Specialist to join our Business Process Control team. As a key player in our organization you will provide critical guidance technical support and compliance oversight for business processes across the EMEA region. You will also lead efforts to maintain certifications for Topcon Europe Medical B.V. and its branches.
In this role you will work with cross-functional teams to develop implement and maintain proactive management systems including the Quality Management System (QMS) ensuring compliance with industry standards such as ISO 9001. As the QMS subject matter expert your expertise will drive continuous improvement optimize business processes and support our goal of achieving operational excellence.
Management System Development & Compliance
- Develop implement and maintain policies and procedures for our management system to ensure compliance with international standards and regulations including ISO 9001.
- Plan conduct and report on internal and external audits identifying gaps ensuring adherence and supporting ongoing certification.
- Lead corrective actions root cause analysis and closure processes following audit findings.
- Ensure system documentation is accurate up-to-date and audit-ready at all times.
Risk Management & Continuous Improvement
- Conduct risk assessments using tools like FMEA fault tree analysis and other structured evaluations.
- Monitor KPIs to identify trends and areas for improvement driving efficiency and system effectiveness.
- Lead continuous improvement initiatives collaborating with teams to optimize processes and maintain compliance.
Cross-functional Collaboration & Support
- Work closely with various departments to resolve quality and compliance issues (CAPAs SCARs NCs).
- Assist business process owners in maintaining and optimizing their documented processes.
- Escalate compliance risks to management proactively and ensure timely resolution.
Training & Knowledge Transfer
- Develop and deliver training sessions on QMS policies procedures and standards.
- Support the execution of protocols helping departments align processes with operational excellence.
Tools & Frameworks
- Manage tools for operational quality frameworks including scheduling tracking and performance dashboards.
Qualifications :
Education & Experience
- Higher professional education (HBO) level of thinking and working.
- At least 3 years of experience improving and optimizing quality management systems preferably in the medical device or pharmaceutical industry.
- Proven track record in planning and leading internal audits of quality and environmental management systems.
- Familiarity with risk management methodologies like FMEA and fault tree analysis.
- Experience with ISO certification processes and regulatory audits (e.g. ISO 9001).
Knowledge & Skills
- In-depth understanding of the ISO 9001 standard and quality management systems.
- Strong knowledge of quality and risk management frameworks including audit procedures and documentation control.
- Excellent analytical problem-solving and communication skills both verbal and written.
- Confidence in working independently and collaborating across departments.
- Proficient in English (Dutch is a plus).
- Ability to train and engage non-technical teams on compliance and quality topics.
- Strong presentation skills and the ability to lead QMS topics with internal teams.
Key Attributes
- Detail-oriented with a methodical approach to problem-solving.
- Strong interpersonal skills and the ability to collaborate effectively with cross-functional teams.
Passionate about continuous improvement and maintaining high-quality standards.
Additional Information :
At Topcon we invest in you. We offer you an interesting international work environment and varied position at a top player in the market. For this position we offer you a reward that depending on knowledge and experience can certainly be called excellent. In addition we offer you an employment package such as:
- Full employer paid pension contribution
- 13th month salary
- 28 vacation days
With a career at Topcon Healthcare you have exciting new possibilities as we are improving human eye health through innovations in examination diagnosis and treatment. Especially today due to rapid population growth aging and mobile devise use we see increased cases in eye conditions. As part of our team you can contribute to continuously improving and accelerating (remote) diagnosis solutions.
Join Topcon
Are you ready for a new challenge and do you recognize yourself in the above profile We invite you to apply for this position and send your CV with motivation.
Note: This position is based at our office in Capelle aan den IJssel and applicants without a valid work permit or who live abroad will not be considered.
Acquisition based on this vacancy is not appreciated.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
