Description:
We’re recruiting for a Quality Engineering Optimisation Manager to join our team based in Pencoed. This role will report to the Senior Manager, Quality Engineering Excellence.
Your New Role
As the 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 be responsible for leading and developing 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 with regulatory requirements while improving product quality, operational efficiency, and reliability.
The Quality Engineering Optimisation Manager works cross-functionally to embed Quality and Compliance principles across the product lifecycle, supporting inspection readiness and operational excellence. Ensuring the team partners cross functionally 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 organizational 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 organizational 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 as applicable.
- Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies, notified bodies, and internal audits.
- Provides CAPA management within scope ensuring timely, effective investigation and resolution of quality issues. Ensuring robust root cause analysis using appropriate methodologies (e.g., 5 Whys, Fishbone, FMEA) and that sustainable corrective and preventive actions are implemented.
- Provides quality support and leadership for process, equipment and facility changes including validation support. Ensuring validation strategies meet regulatory requirements and industry best practices.
Process Improvement: 30%
- Support harmonization and standardization 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 (QMS).
- Monitor Quality performance using metrics and data analytics to identify risks, drive root cause analysis, and implement sustainable improvements.
Required Skills
What you’ll need to succeed:
- Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required.
- Demonstrated experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including experience 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 organizational boundaries.
- Strong analytical and problem-solving skills, with experience using data to drive decision-making and improvement.
- Experience leading in a matrixed, global organization 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 optimizing 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.