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, molecular testing, clinical chemistry and transfusion medicine. With more than 6,000 employees across 130 countries, we provide fast, accurate, and consistent testing to support healthcare worldwide.
Role Summary
The Global Compliance Engineer will support audit and inspection readiness activities of QuidelOrtho’s global quality system at our manufacturing facility in Pencoed. This permanent role offers hybrid working but requires the ability to travel to sites on short notice.
Responsibilities
* Coordinate global regulatory inspections at QuidelOrtho sites, including preparation activities, overall management strategy, and logistics before and after inspection (End‑to‑End inspection coordination).
* Lead inspection readiness meetings for the Pencoed, UK manufacturing sites, and other sites as required; develop strategy, assess risk, and prepare subject‑matter experts and inspection staff.
* Support pre‑ and post‑activities for external inspections at Pencoed, UK, and other manufacturing/distribution sites, and liaise with Notified Bodies, Regulatory Agencies, and other partners via document preparation, audit oversight, SME readiness, response writing, tracking, and follow‑up.
* Provide support for other external audits as required by the group.
* Conduct and support internal audits, including preparation, oversight during execution, review of audit reports, and follow‑up activities for audit closure.
* Maintain the QuidelOrtho Global Audit tracker and produce reports for overdue and upcoming audit records for the QSE, Planning & Monitoring team.
* Perform other related duties as assigned.
Qualifications & Experience
* Bachelor’s degree in science, engineering, QA, RA, or a related business field, or equivalent job experience.
* Previous experience in compliance processes within regulated biologics, pharmaceutical and/or medical device environments.
* Expert knowledge of quality compliance and experience in global internal/external audits.
* Strong skills in MS Word, Excel, PowerPoint, Adobe, and quality system database applications such as Windchill, MasterControl, and eDMS.
* Excellent attention to detail, grammar, proofreading, interpersonal, and communication skills.
* Ability to maintain confidentiality and professionalism.
* Up to 15% domestic and/or international travel.
* Preferred background in IVDD directives, IVDR regulations, ISO 13485/9001, and MDSAP standards.
Benefits
* Competitive Salary and yearly salary reviews.
* Agricultural pension scheme.
* Bonus scheme.
* Life assurance.
* Private medical (if applicable).
* LinkedIn Learning.
* Cycle to work scheme.
* Free onsite gym.
* Subsidised canteen.
* 25 days holidays plus 8 bank holidays (milestone increases available).
* Employee assistance programme.
* Reward and recognition programmes.
* State‑of‑the‑art facilities and strong culture focused on collaboration and customer satisfaction.
Equal Opportunity Statement
QuidelOrtho is committed to ensuring all individuals have the opportunity to apply for positions 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. We provide reasonable accommodations to qualified individuals to enable them to perform their job‑related duties. Please contact recruiting@quidelortho.com if you require a special assistance or accommodation to apply.
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