SRG are recruiting on behalf of an exciting and progressive Medical Device company in Cambridge who are looking to add a Supplier Quality Engineer to the team. You will provide support to the Global Supplier Quality organization dedicated to the oversight of suppliers. You will provide technical knowledge across the organization to ensure suppliers can meet all requirements.
Qualifications / Education / Experience / Skill Required
Education
1. Bachelor's degree preferred in a related Engineering field.
2. ASQ Supplier Quality Engineer Certificate (desirable).
Experience
1. Experience in medical device manufacturing or related industry.
2. Experience of working in supplier quality.
1. Be an ISO 13485 lead auditor - REQUIRED.
2. Understand and be proficient in Risk management - REQUIRED.
3. Understand and be proficient in Validations and root cause analysis.
4. Understand and be proficient in PPAP (Desirable).
5. Proficiency with eQMS platforms.
6. Communication - must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
7. Working knowledge of major Medical Device Regulations, cGMP, CFR 820, MDR 2017/745, MDSAP, ISO-13485, ISO-14971, ISO-9001 (Desirable).
8. Knowledge of project management techniques.
9. Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
10. Ability to analyze a situation or data; evaluate relevant identifiable factors and translate this information into a meaningful proposal or action plan.
11. Must be able to work independently and with all levels of the organization.
12. Ability to effectively communicate ideas and approaches in the form of proposals, plans, and presentations.
13. High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.
14. Ability to handle and manage multiple complex projects.
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