Senior Specialist, Device Development Assurance

at  Viatris

McDermott Laboratories Limited
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
As a Senior Specialist, Device Development Assurance you will be responsible for supporting the ongoing maintenance and improvement of the Quality Management System. As part of the responsibilities of the role, you’ll be compiling, analysing and presenting data to measure and report on the organisation’s performance against established quality objectives, ensuring continuous improvement and compliance with regulatory requirements.

Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist, Device Development Assurance role will make an impact:

• Maintain and enhance the QMS to ensure compliance with ISO 13485 standards.
• Support the internal audit program as well as third-party inspections.
• Support the identification and generation of new and updated Quality System documentation, including SOPs and WIs.
• Compile and reporting data on the performance of the organisation against quality objectives.
• Support the execution of Internal Audits, third-party inspections/audits, and corporate Quality audits.
• Support the management and execution of change control (internal and external).
• Support the CAPA process, including identifying root causes, developing and implementing corrective actions, verifying the effectiveness of actions taken, and ensuring timely closure of CAPAs in compliance with quality management systems and regulatory requirements.
• Stay abreast of updates to relevant standards, regulations and industry best practices, particularly as they pertain to core QMS processes and ensure changes are communicated clearly and reflected in updates to relevant SOPs.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree in Science, Engineering or Biotechnology.
• 5 years relevant professional experience (GMP / Medical Device Industry quality operations).
• Demonstrated ability to perform in a high-performing workforce.
• Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745.
• Strong problem solving and analytical skills.
• Excellent communicator.
• A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business.
• Proficient in MS Office applications.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
https://www.viatris.com/en/Careers/Diversity-and-Inclusion
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit
https://www.viatris.com/en/about-us/corporate-responsibility
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.

Every day, we rise to the challenge to make a difference and here’s how the Senior Specialist, Device Development Assurance role will make an impact:

• Maintain and enhance the QMS to ensure compliance with ISO 13485 standards.
• Support the internal audit program as well as third-party inspections.
• Support the identification and generation of new and updated Quality System documentation, including SOPs and WIs.
• Compile and reporting data on the performance of the organisation against quality objectives.
• Support the execution of Internal Audits, third-party inspections/audits, and corporate Quality audits.
• Support the management and execution of change control (internal and external).
• Support the CAPA process, including identifying root causes, developing and implementing corrective actions, verifying the effectiveness of actions taken, and ensuring timely closure of CAPAs in compliance with quality management systems and regulatory requirements.
• Stay abreast of updates to relevant standards, regulations and industry best practices, particularly as they pertain to core QMS processes and ensure changes are communicated clearly and reflected in updates to relevant SOPs

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• Bachelor’s degree in Science, Engineering or Biotechnology.
• 5 years relevant professional experience (GMP / Medical Device Industry quality operations).
• Demonstrated ability to perform in a high-performing workforce.
• Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745.
• Strong problem solving and analytical skills.
• Excellent communicator.
• A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business.
• Proficient in MS Office applications