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| Job Location | Pune |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | Quality (QA-QC) |
| EmploymentType | Full-time |
Why join Medline: A direct, full - time employment in a large, stable, rapidly growing and yet profitable company. Privately owned company with no public debts. No ill effects of recent downturn/recession. First - rate compensation and benefits package. Genuine individual growth potential in this new establishment. Open door and highly ethical work culture, with due accountability. Function Summary : Support all Quality functions for Medline s Operating Room product division in the EU. Supports the development of internal QRA systems and procedures. Reports to the European Operations Quality Manager Main activities : Responsible for supporting all Quality functions for Medline s Operating Room product division in the EU. Responsibilities include planning, organizing, reviewing, and otherwise ensuring the completeness of validation activities for operating room products to achieve compliance with international standards and regulations. This position will contribute to the construction and completion of CE technical files, DHFs, DMRs, and other quality & regulatory documentation as necessary. Validation activities includes evaluation of supplier documents (Physical, chemical & biological, packaging/transportation/ageing studies) for missing information/documents and development of Biological evaluation plan & report. Initiation & coordination with laboratories for development of product specific test reports. Additionally, this position is responsible for design & development planning and documentation, design control, design transfer, supplier quality support and controls, inspection review, complaint investigations, implementation of corrective action plans, annual Post Market Surveillance, and Risk Management file review. Development & maintenance of product specification/GPI. Involve in development of procedures related to validation activity. Secondary activities : Performing regulatory gap analysis. Involve in development of procedures related to validation activity. Assist in other Quality and Regulatory areas as necessary to support goals and objectives (Supplier Change Control, Quality Systems, Quality Audits, etc.). Qualifications : Experience within a Medical Device industry with a strong Quality background. Knowledge and good understanding of ISO 13485, ISO 10993 & other relevant ISO/ASTM standards. Understanding of regulatory requirements of European Medical Device Regulation (EU MDR). Good technical writing skills. Good level of English (oral and written): able to communicate with the teams located at Chateaubriant France, Shanghai - China and US. Ease for reading/creating/modifying documents. Good technical report writing skills. Well organized, rigorous, Able to work with minimal supervision. Self - motivated team player. ,
Keyskills :
iso quality inspection calibration ostmarketsurveillance designcontrol qualitycontrol iso13485 operatingroom qualityaudit changecontrol riskmanagement reportwriting iso10993