About the Role:
This position has responsibilities for the deployment and standardization of key Quality Assurance activities including assurance of product quality, quality planning process, and maintenance of Quality Management System performance. This role will carry out responsibilities in strict adherence to regulatory requirements and applicable standards relevant to medical device, and always act with focus on quality objectives within the organization.
Roles and responsibilities:
- Functional lead for implementation, managing operational effectiveness of Complaint Handling process, trending activities, and analysis of data associated with defined KPIs.
- Responsible for monitoring and implementation escalation process and resolution for late medical device reports caused by late entries by local intake team.
- Analyze and recommend complaints received are reportable within the market, ensure adverse events reported to Authority if needed, with special attention to managing complaint-adverse event with close follow up with manufacturer and/or reporter.
- Execute, coordinate and feedback Field Corrective Action/Recalls with the countries, maintain tracking to monitor field actions in the region to ensure effective resolution or closure. Report Field Corrective Action to Authority if needed.
- Support audit readiness, conduct and prepare for regulatory/external audits as well as internal quality audits to ensure timely execution according to defined schedule.
- Participate of Nonconformity, Corrective and Preventive Actions, Documentations, Supplier Quality across the organization.
- Develop/update procedures for quality system processes to ensure alignment with Olympus global procedures as well as coordinate with other departments that effect Quality Systems.
- Provide training and support to employees concerning quality systems, policies, procedures, and core processes etc.
- Support global and local quality improvement initiatives and transformative projects.
- Execute other tasks and projects, as assigned by Manager.
About Olympus:
Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that make a positive contribution to society.
Our products are used to capture the medical and diagnostic images of our world, from the microscopic to the endoscopic. They are instrumental in furthering research, and for travelling inside the human body to help diagnose, treat and prevent illness.
Our commitment to customers and our social responsibility is the cornerstone of everything we do.
Why work at Olympus?
At Olympus, we are dedicated to fostering a high-performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact and Empathy, form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.
Not only will you benefit from a meaningful, rewarding and challenging career, you will have access to a range of benefits:
- A competitive salary package including AWS and Variable Bonus
- Hybrid home office work arrangements
- 18 days of annual leave in your first year
- Health and Wellbeing initiatives (Annual Medical Checkups, Flu Vaccinations, Dental benefits, and Employee Assistance Programs)
What we are looking for:
- Bachelor’s degree in related field of engineering, science, or equivalent discipline.
- At least 5 years of experience working in similar position of responsibility in the medical device quality field
- Prior experience in managing quality management system in a medical device environment and quality assurance/regulatory compliance
- Must have knowledge to perform quality audit, certified auditor in ISO13485 or GDPMDS will be a plus.
- Strong knowledge of quality system requirements and medical device regulatory framework
- Meticulous and strong attention to details
- Excellent verbal and written communication skills
- Good problem solving and ability to drive change within organization
- Ability to succeed in a fast-paced, matrixed environment with speed, accuracy and adaptable to meet business need
- Positive attitude and able to work well as team player
Apply Now:
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