CIN: U74999TG2018PTC122995

Position Summary: Manager of Quality Assurance & Project Management

Makers Hive Innovations Pvt. Ltd.
General Job Purpose

We are looking for a reliable Manager of Quality Assurance & Project Management to
ensure that all external and internal requirements are met before our product reaches our
customers. You will be responsible for inspecting procedures, and outputs, processes,
regularity compliance requirements, and identifying mistakes or non-conformity issues.

The goal is to assure the high quality of our operations and services aiming to the long-term
success of our business.

Reporting to: CTO

A. Job Responsibilities:

Responsibilities:

1. Maintaining QMS and being responsible for the overall quality of the process and
oversee the management and compliance with the procedures, data models,
policies, and technologies associated with the process.

2. Conducting regular Compliance Audits and risk assessment for all

Products/Projects.

3. Responsible for planning, Scheduling, Execution and Reporting the audits

performed.

4. Identifying root cause and CAPA for the raised non-conformances along with the
engineering team support and help team to implement Change Control Forms.

5. Supporting Product Development teams (Development, testing) for each release in

documentation and Release management.

6. Creating project plans, continuous monitoring of project teams prior to end of each
milestone to limit the process & Project deviations.

7. Work closely with the production manager and management to create SOPs,
organize training sessions.

Address: House no#3-963, Road no#49, Sri Ayyappa Co-operative Housing Society, Madhapur, Hyderabad
500081, India.
Website: www.makershive.io
Email: contact@makershive.io, careers@makershive.io
Contact: 9121170171
 CIN: U74999TG2018PTC122995

8. Develop Roles, tasks, activities, Process, sub process, scenarios and manage issues of
a team or product.

9. Providing support to Project teams in following the process and process documents,
defined in Quality Management System.

10. Maintaining all process documents with version control.

11. Reporting the status of projects to senior management, periodically.

12. Working on improving the QMS and inducting best practices into the Organization.

13. Reviewing plans, procedures and standards to adhere organizational goals and
practices.

14. Proposing corrective actions to overcome the deviations in the actual project plans.

15. Revise procedures to inspect and report quality issues and monitor all operations
that affect quality.

16. Facilitate proactive solutions by collecting and analysing quality data

17. Review current standards and policies

18. Ensure all legal standards are met

B. Education/Experience/Skills:

1. Bachelor of Technology or BSc/BA in business administration or relevant field

2. At least 5+ years of experience in Quality systems and project management
3. Must have hands-on experience in implementation of quality standards like ISO
13485
4. Must have knowledge of regulations such as GDPR, HIPAA and standards such as ISO
27001
5. Good knowledge on agile project management
6. Hands-on experience with project management tools like JIRA, ZOHO Projects.
7. Prior Auditor experience for ISO 9001:2015 or ISO 13485
Address: House no#3-963, Road no#49, Sri Ayyappa Co-operative Housing Society, Madhapur, Hyderabad
500081, India.
Website: www.makershive.io
Email: contact@makershive.io, careers@makershive.io
Contact: 9121170171
 CIN: U74999TG2018PTC122995

8. Knowledge of medical devices industry is a plus

9. Proven experience as a quality assurance manager or relevant role
10. Thorough knowledge of methodologies of quality assurance and standards
11. Good knowledge of MS Office and Excel
12. Outstanding communication skills
13. Great attention to detail and a result driven approach
14. Excellent organizational and leadership abilities
15. Reliable and Trustworthy
16. Spoken English, Telugu and Hindi is a must

For Acceptance:
Name:
Signature:
Date:

Address: House no#3-963, Road no#49, Sri Ayyappa Co-operative Housing Society, Madhapur, Hyderabad
500081, India.
Website: www.makershive.io
Email: contact@makershive.io, careers@makershive.io
Contact: 9121170171