Danaher takes its name from a tributary of the South Fork Flathead River in western Montana. In the early 1980s, this was the setting for the fishing trip where Steven and Mitchell Rales envisioned a new kind of manufacturing company one dedicated to continuous improvement and customer satisfaction. The root “Dana” is an ancient Celtic word meaning “swift flowing,” an apt descriptor for the nimble mindset and rapid flow of innovation that have defined Danaher for decades.
Post : Commercial Quality Specialist
Job Description :
• Responsible for general support and maintenance of the Quality System/Regulatory Compliance within the requirements of the international and national standards such as the QSR, ISO 13485, 98/79/CE Directive for IVD including;
• the document control system, corrective and preventive action system, internal audits and administrative support
• Material quality assurance, batch record issuance, management of the quality documentation.
• Field Safety Corrective Action and Reporting the Adverse Events Report to the competent authorities.
• Ensure compliance as per MDR 2017, European regulations, ISO 9001, ISO 13485, Cepheid corporate quality system requirements.
• Review records and documents, for completeness and compliance with MDR and ISO requirements.
• Review batch record to support release of incoming goods received in quarantine status and final and refurbished products (Gx modules at repair center).
• Support compliance to post market surveillance process; Field Actions, Complaint Handling (Safety and Quality Complaints) & Logistic & Distribution as per law of land of India.
• Support of document control system facilitating document creation and approvals.
• Assist with the implementation of standard operating procedures to define and improve quality system functions.
• Support interdepartmental initiatives for continuous improvement.
• Partner with departments to promote improvements, through the use of training.
• Support the corrective action program in the investigation and resolution of issues.
• Support the electronic documentation process, as needed.
• Participate in the internal auditor program, as needed
Candidate Profile
• Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field
• 2-4 years of experience in the medical devices industry (IVD can be a plus)
• Experience within commercial quality is very beneficial and highly desirable
• Experience with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
• Excellent verbal and written communication skills
• Knowledge of International Organization for Standardization ISO13485
• Knowledge of International regulations QSR for USA, CE Directive and Regulation for India.
• Excellent planning and organizing skill
• Exceptionally strong team player with excellent interpersonal and communication skills
• Able to confidently deal with ambiguous issues and provide input towards suitable actions.
• Experience working with medical device quality systems in compliance with MDR and ISO 13485
• Able to interpret quality problem and establish practical solutions within a dynamic business environment.
• Experience in leading continuous improvement efforts, in both quality systems and products.
• Knowledge of the process of establishing facility QMS certifications.
• Cross functional experience with products and commercial operations processes to influence change at all levels within the organizationVisio and Project knowledge desirable.
Additional Information
Experience : 2-4 years
Qualification : Master’s degree in science
Location : Gurugram, Haryana
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Quality
End Date : 10th June, 2023
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