At a Glance
- Tasks: Coordinate global regulatory inspections and ensure compliance at our manufacturing sites.
- Company: Join QuidelOrtho, a leader in in vitro diagnostics with a collaborative culture.
- Benefits: Enjoy competitive salary, yearly reviews, private medical, and a free onsite gym.
- Other info: Hybrid working with opportunities for travel and career growth.
- Why this job: Make a real impact in healthcare while working with a dynamic team.
- Qualifications: Bachelor’s degree in science or engineering and experience in compliance processes.
The predicted salary is between 50000 - 65000 £ per year.
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 special assistance or accommodation to apply.
Global Compliance Engineer in Pencoed employer: Ortho Clinical Diagnostics
QuidelOrtho is an exceptional employer, offering a dynamic work environment at our state-of-the-art manufacturing facility in Pencoed, UK. With a strong focus on collaboration and customer satisfaction, employees benefit from competitive salaries, comprehensive health plans, and opportunities for professional growth through initiatives like LinkedIn Learning. Our commitment to employee well-being is reflected in our generous holiday allowance, onsite amenities, and a culture that values diversity and inclusion.
Contact Details:
Ortho Clinical Diagnostics Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Global Compliance Engineer in Pencoed
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching QuidelOrtho and understanding their compliance processes. Tailor your answers to show how your experience aligns with their needs, especially in audit readiness and regulatory inspections.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or use online platforms to refine your responses. Focus on articulating your experience in quality compliance and internal audits clearly.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of the QuidelOrtho team.
We think you need these skills to ace Global Compliance Engineer in Pencoed
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Global Compliance Engineer role. Highlight your experience in compliance processes and any relevant qualifications that match the job description. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about compliance in the diagnostics field and how your skills can contribute to QuidelOrtho. Keep it engaging and personal, so we get a sense of who you are.
Showcase Your Attention to Detail:Since this role requires excellent attention to detail, make sure your application is free from typos and errors. We appreciate a polished application that reflects your commitment to quality and professionalism.
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of being noticed. It’s straightforward and ensures your application goes straight to us. Don’t miss out on this opportunity!
How to prepare for a job interview at Ortho Clinical Diagnostics
✨Know Your Compliance Stuff
Make sure you brush up on your knowledge of compliance processes, especially in regulated environments like pharmaceuticals and medical devices. Familiarise yourself with IVDD directives, ISO standards, and any relevant regulations that QuidelOrtho follows.
✨Prepare for Inspection Readiness
Since the role involves coordinating inspections, think about how you would lead an inspection readiness meeting. Prepare examples of how you've managed similar situations in the past, focusing on strategy development and risk assessment.
✨Show Off Your Tech Skills
QuidelOrtho values strong skills in MS Office and quality system databases. Be ready to discuss your experience with tools like Windchill or MasterControl, and maybe even bring a few examples of reports or documents you've created to showcase your proficiency.
✨Communicate Clearly
Excellent communication is key in this role. Practice articulating your thoughts clearly and concisely, especially when discussing complex topics like audit oversight or regulatory agency interactions. Remember, it's not just what you say, but how you say it!
