1. Lead and coordinate the site’s Quality team
2. Provide Quality leadership for investigations, deviations, change controls, validation, SOPs, and in-process controls.
3. Champion collaborative relationships between Operations and Quality to improve customer experience.
4. Assist other functions in troubleshooting and resolving process and quality issues.
5. Work with Operations, R&D, Purchasing, and Engineering to improve quality and reduce costs.
6. Focus on efficiency and compliance improvements in quality management.
7. Partner with Operations to establish controls and inspection points for nonconforming materials, parts, assemblies, and products.
8. Act as the Quality Representative for all quality-related corrective/preventive actions.
9. Ensure compliance with division policies, national and international codes, and safety requirements.
10. Analyse trends, conduct root cause analysis, and implement corrective actions for processes and products.
Minimum Requirements/Qualifications
11. Bachelor’s degree in a scientific subject or related field.
12. Proven experience in a regulated industry, ideally in quality assurance within medical device or pharmaceutical manufacturing.
13. Experience managing and developing a team in a quality environment.
14. Strong background in process control and statistical techniques.
15. Knowledge of medical device regulations, cGMP, EU Regulation, or ISO 13485.
16. Strong interpersonal skills, both oral and written.
17. Self-starter with the ability to produce results from general concepts and direction.
18. Ability to prioritise multiple tasks in a global, multi-site organisation.
19. Effective cross-functional team collaboration.
20. Proficiency in quality tools such as FMEA, SPC, DOE, and Six Sigma/PPI.
21. Strong digital literacy, including SAP, Microsoft Word, Excel, and PowerPoint.
22. Expertise in qualification/validation (process, sterilisation, cleaning, software).
Non-Negotiable Hiring Criteria
23. Excellent interpersonal skills.
24. Strong leadership and influence capabilities.
25. Ability to work independently and as part of a team.
26. Strong quality background and decision-making skills.
27. Ability to address sophisticated issues and align with regulatory standards.
28. Continuous improvement approach.