QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
Global Compliance Engineer
As part of our continued growth, we are seeking a Global Compliance Engineer to join our team at our state-of-the-art manufacturing facility in Pencoed. This is a permanent role offering hybrid working. However, given the nature of the position, the successful candidate will need to be able to travel to site at short notice when required.
Your new role:
As the Global Compliance Engineer, you will be a key member of the Global Compliance team. In your role, you will support audit and inspection readiness activities of the global quality system and processes to assure each area is able to successfully demonstrate compliance during internal and external inspections.
This role reports into the Quality Systems Excellence Manager, Planning and Monitoring.
You will perform Internal audits in accordance with QMS standards and regulatory requirements impacting QuidelOrtho’s global quality system. Liaising with Quality Operations/Global Supply Network Excellence partners to collect, analyze and share information associated with annual audit activities across QuidelOrtho, to assure visibility and consistency across the QRC organisation.
What you’ll be doing:
- Responsible for coordination of global regulatory inspections at QuidelOrtho sites, including the preparation activities, overall management strategy and logistics prior to and post inspection (End-to-End inspection coordination).
- Inspection readiness lead for Pencoed, UK manufacturing sites, and support. Lead regular inspection readiness meetings to develop strategy and determine risk, identify and prepare subject matter experts and inspection staff
- Work closely with site manufacturing lead and key relevant staff.
- Support pre and post activities for external inspections at Pencoed, UK and other manufacturing/distribution sites (as applicable) and liaising with (i.e. Notified Bodies, Regulatory Agencies, etc) via document preparation, audit oversight, SME readiness, response writing, tracking and follow-up activities.
- Provide support for other external audits as required by group.
- Conduct and support internal audits, as assigned. For internal audits conducted by consultants: prepare and provide guidance for agenda, identify SME, provide oversight during audit execution, review report and responsible for audit follow-up activities and closure.
- Support the metrics tracking for the QSE, Planning & Monitoring team such as but not limited to the maintenance of the QuidelOrtho Global Audit tracker and the creating and issuing the report for overdue and upcoming records for audits.
- Perform other work related duties as assigned.
What you’ll need to succeed:
- Minimum of a bachelor’s degree in science, engineering, QA, RA or other related business field or equivalent job experience.
- Previous experience related to compliance processes in a regulated biologics, pharmaceutical and/or medical device environment is required.
- Expert knowledge in quality compliance, and previous experience in global internal/external audits.
- Demonstrable skills in MS Word, Excel, PowerPoint, Adobe, and quality system database applications (i.e. Windchill, MasterControl, eDMS applications).
- Strong attention to detail, excellent grammar and proofreading skills.
- Strong interpersonal and communication skills.
- Able to maintain a high degree of confidentiality and professionalism.
- Up to 15% domestic and/or international travel.
- Background in the IVDD directives, IVDR regulations as well as ISO 13485/9001 and MDSAP standards is preferred.
What we offer:
- Competitive Salary
- Yearly Salary Reviews
- Attractive Pension Scheme
- Bonus Scheme
- Life Assurance
- Private Medical (If applicable)
- LinkedIn Learning
- Cycle to Work Scheme
- Free Onsite Gym
- Subsidised Canteen
- 25 days Holidays + 8 Bank Holidays (Milestone Increases Available)
- Employee Assistance Programme
- Reward & Recognition Programmes
- State-Of-The-Art facilities
- Exceptional career developmental prospects
- Strong culture centred around collaboration & customer focus.
Equal Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at [email protected] .
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