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Senior Engineer - Quality
Flex
posted 30d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world.
We believe in the power of diversity and inclusion and cultivate a workplace culture of belonging that views uniqueness as a competitive edge and builds a community that enables our people to push the limits of innovation to make great products that create value and improve peoples lives.
A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but dont meet every bullet point, we encourage you to apply and join us to create the extraordinary.
To support our extraordinary teams who build great products and contribute to our growth, we re looking to add a Senior Engineer - Quality located in Sriperumbudur.
What a typical day looks like :
- Responsible for leading the quality function with overall responsibility for delivering the entire Quality System to the business and ensuring consistent, compliant best practices in key processes are applied across organization. The position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies.
- Coordinates activities within the organization in support of ISO13485 certification and U.S. FDA 21 CFR Part 820 requirements
- Analyzes, evaluates, and presents information concerning regulatory, certification and quality management factors for consideration by other members of management team.
- Plan and schedule internal audit for medical business as per annual plan.
- Conducts management meetings with quality assurance program department heads to establish, delineate and review program organizational policies, to coordinate functions and operations between departments, and to establish responsibilities and procedures for attaining objectives.
- Reviews technical problems and procedures of departments and recommends solutions to problems or changes in procedures including establishing nonconformance resolutions, corrective actions and preventive actions effectively
- Confers with engineers about quality assurance of new products designed and manufactured products on market to rectify problems.
- Collection of KPIs pertain to medical business and conduct periodic review meeting.
- Responsible for establishing continuous improvement programs for the company, defining and implementing the quality policy and guidelines, and homogenizing the quality systems in order to detect, solve and prevent problems in the manufacturing processes.
- Coordinates projects and activities to achieve and maintain qualification of agency sponsored programs, such as ISO.
- Ensures compliance with Company s Quality System and applicable regulatory requirements including ISO13485 and medical devices regulation for USA.
- Responsible for managing customer audits, regulatory/compliance agency audits, internal audits and process audits.
The experience we re looking to add to our team:
- Minimum 5 +years relevant experience in a Quality, Regulatory Compliance or Document Control related function.
- Experience with medical device industry, as well as in depth knowledge on US Food and Drug Administration (FDA) compliance, ISO13485 and FDA21CFR Part 820 will be an added advantage
- ISO 13485 Internal/Lead auditor certification
What you ll receive for the great work you provide
- Medical insurance
- PTO
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Senior Quality Engineer roles with real interview advice
People are getting interviews at Flex through
People are getting interviews through
(based on 122 Flex interviews)
Job Portal
Referral
Company Website
Campus Placement
Walkin
Recruitment Consultant
36%
16%
12%
11%
11%
3%
11% candidates got the interview through other sources.
High
Confidence
?
High Confidence means the data is based on a large number of responses received from the candidates.
What people at Flex are saying
Senior Quality Engineer salary at Flex
reported by
27
employees
with 9-17
years exp.
₹6.5
L/yr - ₹11
L/yr
At
par with the average Senior Quality Engineer Salary in India
View more details
What Flex employees are saying about work life
based on 2.3k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Flex Benefits
View more benefits
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Flex Sriperumbudur Office Location
Sriperumbudur, Tamil Nadu Office
Plot 3, Phase II, SIPCOT Industrial Estate Sandavellur C, Village
Sriperumbudur, Tamil Nadu
602106
602106
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