Your Responsibilities
* Maintain and develop the Quality Management System (QMS) and its documentation to ensure regulatory compliance.
* Create and manage quality system records.
* Plan and conduct Quality Management training for employees.
* Conduct and support quality audits.
* Support quality system processes such as Document Control, Change Control, Internal and External System Audits, Non-Conformities (NCs), and CAPAs.
* Support and monitor quality metrics and KPIs.
* Assist the QA/RA Department with document change control, revision, and approval processes.
* Process quality compliance incidents and implement improvement measures.
* Monitor and ensure compliance with the ISO 13485 standard.
* Maintain and optimize Quality guidelines, processes, and internal controls.
* Foster and promote a culture of quality within the organization.
* Support environmental and health & safety (H&S) best practices to minimize environmental impact and safety risks.
Education
* Bachelor's or Master's degree in Engineering or an equivalent field.
Experience
* Minimum 2 years of experience in Quality Management Systems.
* Background in Industry or Quality Areas with a focus on:
o Quality Management / Audit Management / Quality Assurance.
o Or relevant professional experience with additional training in this field.
Skills
Your competencies
* Understanding of the regulatory requirements.
* IT know-how.
* Proficiency in English.
* Strong knowledge of NP EN ISO 9001.
* Familiarity with NP EN ISO Preferred).
Soft Skills
* Attention to detail & accuracy.
* Strong organizational skills.
* Ability to multitask & prioritize effectively.
* Excellent interpersonal skills.
* Problem-solving mindset.
* Experience using database programs for documentation control.
Benefits
Your benefits
Compensation & Security
* Competitive Salary: A salary that reflects your skills and experience while remaining competitive in the market.
* Stable Employment: A permanent contract offering long-term career stability.
Well-being in Focus
* Comprehensive Health Insurance: Individual coverage with reduced rates for family members.
* Vacation Policy: 24 vacation days, plus additional time off for your birthday and December 24th.
* Free Curative Medicine Appointments: On-site medical consultations for your health and wellness.
* 24/7 Employee Assistance Program (EAP): Confidential support available every day of the year.
* Flexible Work Model: Hybrid work options, depending on your role.
* Nutritional Options at Work: A diverse canteen offering meat, fish, diet, vegetarian, and salad options.
Culture of Development & Learning
* Unlimited Access to LinkedIn Learning: Expand your skills at your own pace.
* Tailored Training: Initial and ongoing training aligned with your career path.
Other Benefits
* Referral Program: Earn financial rewards for recommending new colleagues.
* Engaging Events: Team buildings, Christmas celebrations, and themed company days.
* Online Wellness Classes: Access to Burnalong Olympus with 40+ categories and 1,000+ instructors.
* Convenient Parking: Facilities for cars, motorcycles, and bikes, including electric car chargers.
About Olympus
At Olympus, we are committed to Our Purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.
For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.
For more information, visit and follow our LinkedIn account: .
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