CORCYM is a global medical device company. It has acquired a complete portfolio of surgical solutions with a heritage spanning more than 50 years. CORCYM employs approximately 850 people in over 100 countries, ensuring a strong presence to continuously support patients, healthcare professionals and healthcare systems worldwide.Join us today and take life to heart!
The incumbent will be responsible for ensuring compliance to all Corcym quality policies and procedures as well as external regulations and standards as applicable: FDA (21 CFR Part 820 and ISO 9001/13485. Primary focus shall be on ensuring compliance to procedures, review changes and manage containment of non-conformances and corrective and preventive actions. The incumbent will work in conjunction with Process Engineering to support Risk Analysis and Validations (Process, Test Methods, Software), and provide support for current manufacturing processes, and product outcomes.Key Responsibilities:
- Communicate quality policy and requirements effectively to all departments.
- Collaborate with other departments and other international company sites.
- Employ quality analysis tools (fish bone, FMEA, 5 Whys) and statistical techniques in conducting root cause investigations, risk analysis and problem solving.
- Take disposition decision on nonconforming products identified in production.
- Perform data analysis to identify opportunities for CAPA and manufacturing process improvements.
- Ensure that validations and procedures comply with regulations
- Review process validation planning, protocols and reports.
- Manage assigned CAPA's, non-conformances and continuous improvement projects.
- Support regulatory submissions, internal, external and supplier audits as required
- Working knowledge of basic statistics, FMEA, project management, root cause analysis will be an asset
- 1 - 5 years of engineering or quality experience in a regulated industry (Pharmaceutical, Medical Device) is desired
- B.Sc. in Science (Chemistry, Physics, or Engineering) or a Diploma in Engineering Technology (Mechanical, Biomedical, Chemical)
Please visit: https://corcym.breezy.hr/to apply