About this Job

What you’ll do:

You will:

- Be conducting independent assessments after each phase to assure completeness and compliance to Design verification and Validation elements.

- Be handling external Standards - Review of original document & changes.

- Provide regulatory guidance and support to project teams for clinical and performance trials.

- Ensure organization remains compliant to the latest revisions/changes of all applicable regulations and standards.

- Ensure complaint investigations and CAPA Systems compliance to Regulatory Requirements.

- Generate and manage submission documents for new products or changes to existing regulatory submissions.

- Act as a corporate liaison between all regulatory agencies concerning medical devices.

- Participate in product safety alert/recall policy development and coordinates recalls.

- Be responsible for reporting adverse events to required regulatory authorities.

- Provide leadership and assistance for the Quality Assurance (including Quality Control) and Regulatory --functions including Training, Document Controls, CAPA, Complaint, Calibration systems.

- Review complaint, internal audit and external audit reports.

- Ensure that appropriate actions (including investigations) are initiated in response to findings.

- Develop coordinated metrics programs for analysing system data and ensures quality statistics are reported to Senior and Corporate Management teams in a timely manner.

- Be responsible for identifying, analysing and developing improvements in productivity, quality and customer service.

- Manage Supplier Quality Assurance and Quality Engineering.

- Assure an effective incoming inspection process.

- Set annual quality goals.

- Review product release processes.

The finer print:-

- Your 5-10 Years of experience adds to our team value

- Your educational qualification in Btech, Mtech, Msc-IT, Department or relevant field builds our knowledge bank overall

What you are good at:

- Authorise stop shipment of products as appropriate.

- Resolving matters pertaining to quality.

- Tracking supplier quality performance measurements for suppliers (KPI’s) and participate in supplier performance reviews.

- Recommending, evaluating and deploying QA tools and technologies that enhance the quality of the product.

- Managing and aligning quality and regulatory strategic initiatives as part of departmental and corporate goals and quality objectives.

- Formulating and oversee implementation of regulatory strategy and activities.

About Azoi Mobile Technologies Pvt. Ltd

About us:
At Azoi our days are spent in the pursuit of innovation, excellence and problem-solving. We have set out to tackle the mounting challenges in healthcare through the use of sophisticated, yet easy-to-use, and readily accessible monitoring technology. We leverage nascent digital health technology to put the power to manage one’s health and wellbeing in every consumer’s hand. And we do this with the dedication of our amazing and dynamic team of domain experts, engineers, scientists, designers and strategists. As a part of the team, you will be expected to give your very best every day; challenged to think outside the box; and contribute meaningfully to the solutions we seek. We are a startup, and we are growing up fast…are you ready to grow with us?

What we have:
- Innovative, participative, transparent & vibrant culture
- An ever-growing, inspiring environment
- Platform to utilize your potential to the fullest
- Help us keep our learning curve high-we are always open to your feedback & suggestions
- Opportunity for growth
- Free meals
- Comfort is of paramour importance to us hence we do not follow a dress code, wear what is comfortable. Plus we encourage the use of equipment which make your functioning more comfortable
- Celebration at Azoi include Birthday Half days/Birthday Spa'; parties, pot lucks, game nights, festival celebration, food fests
- Rewards & recognition at Azoi include, Spa’s; incentive, attractive coupons, trips, dinner with family
- Open forums, team activities, team lunches/dinners
- There’s always candy at your disposal at Azoi (for all your sweet tooth cravings)