Operations Biomedical jobs in Chennai at Advanced Bio Mechanics Pvt. Ltd.

About the internship

Selected intern's day-to-day responsibilities include:

1. Work on establishing approved documents & maintain and continuously improve quality system processes required by international, regional, and national regulatory authorities and standards (e.g. 93/42/EEC, Regulation (EU) 2017/745, ISO13485, FDA QSR)
2. Interpret and comply with ISO standards and other related guidelines
3. Oversee the implementation and ensure the efficiency of the quality system
4. Establish and analyze key performance indicators to evaluate and continuously improve the QMS
5. Support in audits (internal and external)
6. Analyze audit outcomes & ensure ongoing abidance by industry regulatory and quality requirements
7. Work with the engineering team to ensure the project team follows the quality system and PRD process
8. Work on the compilation of regulatory filings (re-registration/new registrations/legal-physical manufacturer transfer) for the key market under guidance and instructions of RA lead/head
9. Coordinate with external stakeholders through various modes (email/phone) to ensure time-bound availability of documents for regulatory application compilation and submissions

Who can apply

Only those candidates can apply who:

1. are available for full time (in-office) internship

2. can start the internship between 16th Mar'21 and 20th Apr'21

3. are available for duration of 6 months

4. have relevant skills and interests

Other requirements

1. Freshers shall apply

2. Bachelor's degree in a biomedical engineering discipline or equivalent degree

3. Good time management skills

4. Basic understanding of EUMDR & ISO 13485

5. Good technical writing skills and communication skills

Perks

5 days a week

Free snacks & beverages

Number of openings

About Advanced Bio Mechanics Pvt. Ltd.

We are a young medical device company operating in the medical devices industry. Our line of products provides respiratory care and lung management to help patients breathe and keep their lungs healthy both inside and outside the hospitals. We are in the process of developing innovative and connected solutions for chronic respiratory patients to allow high-quality respiratory care with intelligent products like airy clearance devices and ventilators.