The Opportunity
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. With over 6,000 employees and operations in more than 130 countries, we provide fast, accurate, and consistent testing wherever it is needed most—home, hospital, or lab.
Our culture prioritises employee happiness, inspiration and engagement, building meaningful connections that link business success to wellbeing. Join us in transforming the power of diagnostics into a healthier future for all.
Quality Engineering Optimisation Manager
This role reports to the Senior Manager, Quality Engineering Excellence and is based in Pencoed.
Your New Role
As Quality Engineering Optimisation Manager, you will provide direction and operational oversight across Quality Engineering, ensuring alignment with global regulatory requirements (ISO 13485, FDA 21 CFR 820, IVDR, and other applicable standards). You will lead and develop a team of Quality Engineers focused on continuous improvement and optimisation of manufacturing and quality processes for in‑vitro diagnostic (IVD) medical devices.
The role ensures robust implementation of Corrective and Preventive Actions (CAPA), validation activities, and process improvement initiatives to maintain compliance while improving product quality, operational efficiency, and reliability.
You will work cross‑functionally to embed Quality and Compliance principles across the product lifecycle, supporting inspection readiness and operational excellence. You will partner with stakeholders to identify opportunities for improvement, drive root cause investigations, and implement sustainable solutions that enhance product and process performance.
What You’ll Be Doing
People Leadership (40 %)
- Lead, develop, and inspire a team of Quality professionals to achieve organisational and individual performance objectives.
- Establish clear priorities, assign responsibilities, and ensure effective resource allocation to meet business and compliance needs.
- Coach and mentor emerging Quality leaders and technical experts to build organisational capability and ensure robust succession planning.
- Model QuidelOrtho’s leadership principles by demonstrating collaboration, accountability, inclusion, and service mindset in all interactions.
Quality Management System Oversight (30 %)
- Provide technical, regulatory, and operational leadership to ensure Quality systems comply with ISO 13485, FDA 21 CFR 820, IVDR, and other applicable requirements.
- Partner with Manufacturing, R&D, Regulatory Affairs, Supply Chain, and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.
- Ensure the team maintains inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
- Manage CAPA within scope, ensuring timely investigation and resolution of quality issues and sustainable corrective and preventive actions using methodologies such as 5 Whys, Fishbone, and FMEA.
- Provide quality support for process, equipment, and facility changes, including validation support, ensuring validation strategies meet regulatory requirements and best practices.
Process Improvement (30 %)
- Support harmonisation and standardisation of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency.
- Promote a culture of continuous improvement by identifying opportunities for simplification, process excellence, and digital enablement within the Quality Management System.
- Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
Required Skills
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline.
- Demonstrated experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including leading and developing teams.
- Understanding of Quality System regulations and standards, including ISO 13485, FDA 21 CFR 820, and IVDR.
- Proven ability to lead and develop high‑performing teams and build future technical and people leaders.
- Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.
- Excellent collaboration, influence, and communication skills across functional and organisational boundaries.
- Strong analytical and problem‑solving skills, with experience using data to drive decision‑making and improvement.
- Experience leading in a matrixed, global organisation and managing competing priorities effectively.
- Commitment to scientific integrity, compliance excellence, and continuous improvement.
Preferred Skills
- Advanced degree (MS, PhD, MBA, or equivalent) in a relevant discipline.
- Experience implementing or optimising global Quality Management Systems (QMS) and digital tools.
- Lean Six Sigma, PMP, or similar certification demonstrating process improvement expertise.
- Experience supporting or leading Health Authority or Notified Body inspections.
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 holiday + 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 those with disabilities, have an opportunity to apply for positions they are interested in and qualify for, without regard to race, religion, colour, 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 recruiting@quidelortho.com.
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