Senior Manager - 2
SUN PHARMA
Date: 2 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Key Responsibilities
- Overview management of Medical Devices development process as per specific product requirements and in line with respective country regulatory guidance
- Generate technical documentation for the product Design History file and Device Master Records as per specific country regulatory guidance
- To support Business in identifying New technologies /Device manufacturing partners and in evaluation of patents
- Designing and Development of assembling and in-process testing machines
- To Partner with Manufacturing ,Engineering /Projects , Quality team to ensure that the transition of products through R&D , Product approval and manufacturing scale up are smooth , timely and cost effective
- To provide quality engineering support to commercial Medical Devices
- Demonstrable Detailed working knowledge of Medical Device Industry
- Complete understanding of “ Drug Device Combination Products “ guidelines of specific countries
- Thorough knowledge in various ISO’s related to Medical Device Development , inprocess testing
- Knowledge on Human Factor Testing and statistical analysis of data
- Knowledge on various manufacturing and assembling process of Medical Devices including materials used in manufacturing of Medical Devices
- Ability to establish good network in developing and execution of Medical Device Projects
- Application knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
- Ability to utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
- Technical knowledge to navigate complex agency regulations of FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
- Should be creative , continually learning and exploring new ideas
- Good team player who works well in a team with strong interpersonal skills , a demonstrated ability to influence his/her peers
- Displays highest level of integrity and confidentiality
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