Data Scientist
Subhag
Job Description
Essential Responsibilities
- Supplier evaluation, selection and re-evaluation through robust assessment process in compliance with ISO 13485 and GMP.
- Assure product conformity throughout supply chain.
- Implement QMS to ensure zero escaping defect.
- Carry out Process Validation, ETO Validation, Packaging Validation at supplier site.
- Prepare regulatory /technical dossiers for CDSCO manufacturing license, CE marking, US FDA requirements.
- Interface with Suppliers, Manufacturing and Sourcing to drive Quality improvements.
- Assure Corrective and Preventive Action plans are developed and executed at all the suppliers in compliance with the CAPA process.
- All other duties as assigned by Quality Director.
Required Qualifications
Must have:
- Bachelor’s degree in Engineering (mechanical or polymer)/Pharmacy/ Science with 10+ years of experience in manufacturing function such as quality assurance, supplier quality assurance, vendor management, manufacturing engineering, etc. in relevant industry such as medical device industry, automotive industry, aerospace industry or general engineering industry.
- Expert knowledge of plastic and silicon moulding processes
- Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details
- Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities
- Superior ability to lead change with global, cross-functional teams & proven ability to drive operational excellence
Good to have:
- Expert knowledge of Good Manufacturing Practices & Regulatory requirements, ISO 13485, ISO 14971, India Medical Devices Rules, US FDA 21 CFR 820, EU MDR
Desired Characteristics
- Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. …
To apply for this job please visit subhag.in.
