Quality Management Specialist: Quality Assurance and Regulatory Compliance Professional
Há 4 dias
Olympus EMEA is seeking a highly skilled Quality Management Specialist to join our team. As a key member of our quality assurance department, you will play a critical role in ensuring the highest standards of quality and regulatory compliance across our operations.
Key Responsibilities- Maintain and develop the Quality Management System (QMS) and its documentation to ensure adherence to regulatory requirements.
- Create and manage quality system records, ensuring accurate and timely documentation of all quality-related activities.
- Plan and conduct quality management training for employees, promoting a culture of quality awareness and understanding throughout the organization.
- Conduct and support quality audits, identifying areas for improvement and implementing corrective actions to ensure ongoing compliance.
- Support quality system processes, including document control, change control, internal and external system audits, non-conformities, and corrective actions.
- Monitor and analyze quality metrics and KPIs, providing insights and recommendations for process improvements.
- Collaborate with the QA/RA Department to ensure seamless document change control, revision, and approval processes.
- Process quality compliance incidents, identifying root causes and implementing effective corrective actions to prevent recurrence.
- Ensure ongoing compliance with the ISO 13485 standard, maintaining a proactive approach to quality management.
- Maintain and optimize quality guidelines, processes, and internal controls, fostering a culture of continuous improvement.
To succeed in this role, you will require:
- A Bachelor's or Master's degree in Engineering or an equivalent field.
- A minimum of 2 years' experience in quality management systems, with a strong background in industry or quality areas.
- Proficiency in English and excellent communication skills, both written and verbal.
- A solid understanding of regulatory requirements and quality management principles.
- The ability to work effectively in a team environment, collaborating with colleagues to achieve shared goals.
- Strong organizational skills, with attention to detail and accuracy.
- Experience using database programs for documentation control.
Olympus EMEA offers a comprehensive benefits package, including:
- Competitive salary and stable employment opportunities.
- Comprehensive health insurance, with reduced rates for family members.
- Vacation policy, including 24 days off and additional time for your birthday and December 24th.
- Free curative medicine appointments, available on-site.
- Confidential employee assistance program (EAP), offering 24/7 support.
- Flexible work model, with hybrid options depending on your role.
- Nutritional options at work, including meat, fish, diet, vegetarian, and salad choices.
We are committed to your growth and development, offering:
- Unlimited access to LinkedIn Learning, empowering you to expand your skills at your own pace.
- Tailored training, aligned with your career path, to support your professional growth.
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