Quality Assurance Specialist, Device Development Assurance

4 months ago

Dublin, Ireland Viatris Full time
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

The Quality Assurance Specialist will be responsible for supporting the ongoing maintenance and improvement of the Quality Management System. The Quality Assurance Specialist is responsible for 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 Quality Assurance Specialist, Device Development Assurance role will make an impact:

Provide Quality oversight of development laboratory activities against local Global Device Development (GDD) procedures, Global Viatris Policies, and product specific requirements, including but not limited to:

Test Equipment Management – Qualification, Calibration, Preventative Maintenance, Traceability

Material controls – Receipt, Inspection, Storage and Traceability

Test Method Validation

Stability product management oversight

Continuous Improvement – Procedures, Work Instructions, CAPA, Investigations

Support the general development and improvement of the GDD Quality System through management of CAPA, Internal Audit program, documentation, complaints, trending and training

Support third-party inspections/audits

Quality oversight of development laboratory activities

Support CAPA, Internal Audit program, documentation, complaints, trending and training

Support third-party inspections/audits

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

Minimum 3-5 years relevant professional experience (GMP / Medical Device Industry quality operations)

Demonstrated understanding of GMP, ISO13485, CFR 820, MDD 93/42/EEC & MDR 2017/745

Strong problem solving and analytical skills

Possess knowledge of core manufacturing / laboratory operation principles

Excellent communicator; clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines

A team player willing to support any other organisational needs/activities outside primary expertise to continuously develop the business

Demonstrated ability to perform in a high-performing workforce

Ability to work independently and with minimal direction

Ability to define, organize, and manage individual and team tasks

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

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

At Viatris, we offercompetitivesalaries, benefitsandan 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.

  • Senior Quality Assurance Specialist, Device Development Assurance

    4 months ago

    Dublin, Ireland Viatris Full time

    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...

  • Director, Quality Assurance

    1 month ago

    Dublin, Ireland Optum Full time

    Director, Quality Assurance – Dublin or Letterkenny / Hybrid  As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2,000 talented individuals.   With a strong ecosystem of...

  • Director, Quality Assurance

    3 months ago

    Dublin, Ireland UnitedHealth Group Full time

    Director, Quality Assurance – Dublin or Letterkenny / Hybrid As a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and...

  • Quality Assurance

    2 months ago

    Dublin, Ireland PSC Biotech Ltd Full time

    About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...

  • Quality Assurance Analyst

    3 weeks ago

    Dublin, Ireland UniJobs Full time

    Quality Assurance Analyst Unijobs on behalf of our public sector client have a requirement for a Quality Assurance Analyst to join their team. The duration of the post is initially 6 months with possible extensions thereafter. Working 35 hours per week the successful candidate will be employed as an agency employee and will be paid an hourly rate of €29.87...

  • Medical Device Tendering Specialist

    5 days ago

    Dublin, Ireland Independent Search Solutions Full time

    One of Irelands largest Medical Device Distributors has a role for a Contracts and Tendering Specialist. They need a person in-house who can bring to together all the key stakeholders, centralising all the relevant information and ensuring maximum results across all Healthcare Divisions. With customers across the 32 counties of Ireland and an extensive...

  • Customer Assurance Specialist

    4 weeks ago

    Dublin, Ireland RSA Insurance Ireland Limited Full time

    Join RSA and make a difference every day.  Whether you are just beginning your career or looking to take the next progressive step in your journey, RSA Insurance Ireland is an organization where you can be yourself, learn and develop and a place where your ideas and contributions matter. With offices in Belfast, Galway, and Dublin , we have embraced...

  • Quality Assurance Technician

    6 days ago

    Dublin, Ireland INFORM3 Recruitment Full time

    Job Title Quality Assurance Technician Job Location NorthCo. Dublin Salary €40K - €50K About the Company: Are you an experienced individual within the food Manufacturing sector as a Quality Technician? Out client is currently recruiting for a Quality Assurance Technician to support the Quality Manager and Technical Management function within the...

  • Device Supplier Assurance student placement

    1 month ago

    Dublin, Ireland Viatris Full time

    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...

  • Quality Assurance Manager

    2 months ago

    Dublin, Ireland Clinigen Full time

    Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.We are currently 1,100 people headquartered in the UK with global...

  • Clinical /Quality Assurance Manager

    3 weeks ago

    Dublin, Ireland Life Science Recruitment Ltd Full time

    Clinical /Quality Assurance Manager Our client is a not-for-profit organisation providing care delivery to their service users in their own home in the North Dublin area. They are looking to expand their team by the addition of a Clinical/Quality Assurance Manager who will oversee the companys Clinical & Quality policies by monitoring & instilling a high...

  • Training Analyst-Quality Assurance

    3 weeks ago

    Dublin, Ireland UnitedHealth Group Full time

    Training Analyst, Quality Assurance- Dublin or Letterkenny / HybridAs a Fortune Global top 10 business, we’re one of the world’s leading healthcare companies. We have been supporting global healthcare systems from Ireland for 25 years, building a dynamic and diverse team of more than 2, talented individuals.With a strong ecosystem of investment and...

  • Quality Assurance Technician

    2 weeks ago

    Dublin, Ireland Quorum Search Partners Full time

    Our client is an award winning, leading FMCG company based in North Dublin. They are looking for a Quality Assurance Technician to join their Quality & Technical team. Reporting to the Quality Lead Technologist and the Head of Quality & Technical, the QA Technician will play a key role in the business. Package 20 days of annual leave per annum Access to...

  • Quality Assurance and Training Supervisor

    3 weeks ago

    Dublin, Ireland UniJobs Full time

    Quality Assurance and Training Supervisor Unijobs on behalf of our public sector client have a requirement for a Quality Assurance and Training Supervisor to join their team. The duration of the post is initially 3 months with possible extensions thereafter. Working 35 hours per week the successful candidate will be employed as an agency employee and will be...

  • Quality Assurance Analyst

    3 months ago

    Dublin, Ireland ISC Full time

    Company Name:Enterprise Registry Solutions LimitedLocation: Dublin, IrelandStatus: Full–Time Permanent We areERS, a leading international registry provider operating out of Dublin, Ireland. We design, build, and operate registry solutions that power public and private sector operations and drive efficient business decisions around the world. Our people...

  • Senior Quality Assurance Associate

    4 months ago

    Dublin, Ireland TEAM HORIZON Remote Work Freelance Full time

    Description Team Horizon is seeking a Senior Quality Assurance Associate for our Client, who are a leading biotechnology company based in Dublin. Why you should apply: This is an excellent opportunity to join a forward thinking company and work in a state of the art facility. What you will be doing: Testing of primary and secondary...

  • Assurance Specialist

    2 months ago

    Dublin, Ireland Aviva Full time

    Individually we are people, but together we are Aviva. Individually these are just words, but together they are our Values – Care, Commitment, Community, and Confidence. We are looking for an Assurance Specialist to join our team in Dublin. The successful individual will be responsible foridentifying trends/areas of concern and completing reviews of...

  • Software Design Assurance Engineer

    5 months ago

    Dublin, Ireland Pale Blue Dot® Recruitment Full time

    Our Client, an Irish Medical Device Developer which is currently at a really exciting stage in the product life cycle, is looking for a Software Design Assurance Engineer to join their team. The successful candidate will work closely with colleagues to support the development, qualification, and commercialization of innovative, highly reliable, life changing...

  • Assurance Officer

    3 months ago

    Dublin, Ireland AXA Group Full time

    We’re recruiting for an Assurance Officer to join the Assurance Team under the Risk & Compliance Function. At AXA, diversity and inclusion means empowering people to be 100% themselves at work. We work smart, empowering our people to balance their time between home and the office in a way that works best for them, their team and our customers. You'll...

  • Sustainability Assurance

    6 days ago

    Dublin, Ireland Deloitte Ireland LLP Full time

    Deloitte is the biggest professional services Firm in the world making an impact is more than just what we do: it's why we're here. We're driven to create positive progress for our clients, community, people, and the planet. This sense of purpose inspires us to work to the highest standards, to tackle the challenges that matter. Audit & Assurance is one of...