Senior Engineer - Quality

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 people's 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 don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Job Summary

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

PV14

Job Category

Quality

Required Skills:

Optional Skills:

Flex pays for all costs associated with the application, interview or offer process, a candidate will not be asked for any payment related to these costs.

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).