Premium Employer
i
This company page is being actively managed by
Hexaware Technologies Team. If you also belong to the team, you
can get access from
here
Hexaware Technologies
Compare
All Filters
270 Hexaware Technologies Jobs
Test Lead - Automation
5-7 years
Kolkata, Mumbai, New Delhi + 4 more
1 vacancy
Test Lead - Automation
Hexaware Technologies
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
The Senior Quality System Engineer is responsible for the day to day management of the electronic quality management systems and driving process improvement initiatives across the quality organization.
This position collaborates closely with Post Market Quality Complaints, Enterprise Systems, Operations,Supplier Quality, and Quality Assurance.
As part of our team, your core responsibilities will be:
1. Quality Management System:
- Service as the Administrator for all Quality management Systems.
- Responsible for implementation, lifecycle management, maintenance and configuration of eQMS , in accordance with change control processes.
- Assess implementations, updates and upgrades to eQMS to determine the need for revalidation; coordinate internal revalidation activities.
- Translate User Requirements into Functional Requirements.
- Coordinate, create and/or execute validation activities including, but not limited to
- Planning, Requirements, Protocols, UAT.
- Coordinate and lead projects related to the Butterfly eQMS :
- Collaborate with cross-functional process owners and stakeholders to configure quality
- process modules to enhance compliance and efficiency.
- Continuously gather feedback to ensure the eQMS continues to meet the needs of the organization and
- is scaling appropriately.
- Responsible for troubleshooting and resolving eQMS issues.
- If required, record and report issues to the vendor and see them through resolution
2. CAPA/NCE Management:
- Lead investigations of assigned CAPAs/NCEs
- 3. Audit Coordination:
Support and manage (as assigned) the internal and external audits to evaluate the adherence to - quality standards, regulations, and QMS procedures.
- 4. Document Control:
- Oversee the management of QMS documentation and records in Omnify, ensuring accuracy,
- version control, and compliance with document control procedures.
- 5. General Quality Affairs Support:
- Perform a broad variety of tasks in support of the role and responsibilities including, but not limited
- to:
- Responsible for performing gap assessments to plan Quality Objectives and improvement
- initiatives
- Responsible for contributing to the continual quality of Butterfly Network s process
- improvement initiatives.
- Ensuring that policies, procedures and practices are in compliance with global regulatory
- requirements and are aligned with our Quality Policy.
- Responsible for performing tasks to support the quality system and quality policy as
- directed by QA management including, but not limited to Quality Review Board,
- Management Review and supporting internal/external audits.
Qualifications
- Baseline skills/experiences/attributes:
- Bachelors degree
- 5-7 years of experience in medical device quality management.
- Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g.,
- FDA, ISO, GMP).
- Proficiency in electronic Quality Management Systems.
- Demonstrated experience in leading and participating in internal and external audits.
- Excellent analytical, problem-solving, and communication skills.
- Ability to build and maintain cross-functional working relationships.
- Ideally, you also have these skills/experiences/attributes (but it s ok if you don t !):
- Certification in Quality Management (e.g., Certified Quality Auditor) is a significant advantage
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Automation roles with real interview advice
What people at Hexaware Technologies are saying
Automation salary at Hexaware Technologies
reported by
1
employee
with 2
years exp.
₹16.2
L/yr - ₹20.7
L/yr
470%
more
than the average Automation Salary in India
View more details
What Hexaware Technologies employees are saying about work life
based on 5.6k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Hexaware Technologies Benefits
Submitted by Company
Group Mediclaim Insurance Skill Upgradation Paid time off Rewards and Recognition
Submitted by Employees
View more benefits 
Compare Hexaware Technologies with
Cognizant
Compare
TCS
Compare
Infosys
Compare
Wipro
Compare
HCLTech
Compare
Tech Mahindra
Compare
LTIMindtree
Compare
Mphasis
Compare
KPIT Technologies
Compare
Persistent Systems
Compare
DXC Technology
Compare
NTT Data Information Processing Services
Compare
Sutherland Global Services
Compare
eClerx
Compare
Coforge
Compare
Virtusa Consulting Services
Compare
L&T Technology Services
Compare
CGI Group
Compare
Cyient
Compare
GlobalLogic
Compare
Similar Jobs for you
Hexaware Technologies Chennai Office Locations
Chennai Office
Hexaware Technologies, H5, Sipcot IT Park, Navallur Post, Kancheepuram District
Chennai
Tamil Nadu 603103
Tamil Nadu 603103
Chennai Office
Hexaware Solutions Pvt. Ltd, T Nagar
Chennai
Tamil Nadu 600006
Tamil Nadu 600006
UK/US Payroll - Sr. Officer/Team Lead - Navi Mumbai
4-8 Yrs
₹ 4.75 - 5.5L/yr
Navi Mumbai
Hiring For Fresher and Experience||Customer Service
0-4 Yrs
₹ 1 - 3L/yr
Navi Mumbai
Openings For freshers || Night Shift || Customer service
0-4 Yrs
₹ 1 - 3.25L/yr
Navi Mumbai
Share an Interview