About the Role:
This position has responsibilities for the deployment and standardization of key Quality Assurance (QA) activities including assurance of product quality, quality planning process, and maintenance of Quality Management System performance. This role will carry out responsibilities in practical adherence to regulatory requirements and applicable standards relevant to the medical business, and always act with focus on quality objectives within the organization.
Roles and responsibilities:
· Ensure correct implementation and maintenance of Quality Systems throughout the organization, with continuous process improvement in adherence to regulatory requirements.
· Develop/update procedures and SOPs for quality systems 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 audit readiness, conduct and prepare for regulatory/external audits as well as internal quality audits to ensure timely execution according to defined schedule.
· Manage complaint handling process according to global requirements and regulations.
· Execute recall / field corrective actions and other post-market surveillance within impacted countries in the region.
· Participate in handling of Nonconformity, Corrective and Preventive Actions, Documentations, Supplier Quality across the organization’s sites.
· Communicate appropriate quality standards to relevant stakeholders in driving overall site performance and help building culture of quality and continuous improvement.
· Assist administration of management review process, including maintaining compliance to quality system data metrics analysis, monitor and trend quality indicators to proactively report or escalate issues to QARA Manager.
· Support global and local quality improvement initiatives and transformation projects.
· Execute other tasks and projects, as assigned by QARA 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 Integrity, Empathy, Long-Term View, Agility and Unity 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 experience.
- Prior experience working with quality management system and quality assurance / regulatory compliance
- Demonstrate knowledge to perform internal quality audit
- Minimum 3 years of relevant experience in medical device field
- Good knowledge of quality system regulations and medical device regulatory framework
- Meticulous and strong attention to details
- Excellent verbal and written communication skills
- Good problem solving and influencing skills
- Ability to manage multiple activities in a fast-paced environment with speed and accuracy
- Positive attitude and able to work well as team player
Apply Now:
To submit your interest in this opportunity, select “Apply for this job”.
In the meantime, follow us on:
- LinkedIn - Olympus APAC
- Company website -www.olympus.com.sg
