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 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 Description
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add an Engineer - Quality located in Bangalore.
What a typical day looks like:
- Should develop and initiates standards and methods for inspection, testing and evaluation.
- Will be responsible to devise sampling procedures and designs and develops forms and instructions for recording, evaluating and reporting quality and reliability data.
- Will develop and implements methods and procedures for disposition of discrepant material and devises methods to assess cost and responsibility.
- Responsible to direct workers engaged in measuring and testing product and tabulating data concerning materials, product or process quality and reliability.
- Responsible for compiles and writes training material and conducts training sessions on quality control activities.
- Involved in preparing Internal Audits plan. Performing internal audits to verify compliance and conformance to all regulatory and Quality & EHS systems requirements, including both Customer and Flex mandated.
- Will be supporting Product Engineers and Quality Program Managers with customer interfaces as necessary on quality related issues.
- Responsible to assures data availability and integrity for all quality related data. Consolidates and reports quality results.
- Will be responsible to initiate corrective action requests as needed and tracks to satisfactory completion.
- To give support for the development and implementation of quality audits.
- Responsible for developing, applying, revising and maintaining quality standards for processing materials into partially finished or finished products.
- Responsible to carry out designs and implementation methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
- Responsible to study the reports and returned products and recommends corrective action.
- Responsible to establishes program to evaluate precision and accuracy of production equipment and testing, measurement and analytical equipment and facilities.
- To officially accept product, process and equipment qualifications.
- Provides liaison to various regulatory bodies
The experience we’re looking to add to our team
- Diploma / BE /B.Tech graduates with 4+ years of relevant work experience
- Work Experience in establishing Internal Quality & EHS Systems Manuals and Level 1 Procedures, Manufacturing / Service work instructions, Forms.
- Preferred experience in implementation and ensuring effectiveness of the applicable Regulations, Standards, Policies, Directives and Level 1 Procedures in the organization.
- Internal auditor certificate for QMS & EHS Management system (ISO 9001, ISO 14001, ISO 45001, TL, ISO 13485)
- Should possess training/Knowledge on Regulations and IDE and Clinical trials applications in accordance with MDD Annex X, ISO 14155 standard.
- Proficient knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601 and related particular standards.
- Should have an excellent understanding and practical application of medical device quality system regulations, e.g., 21 CFR 820, ISO 13485 and ISO 14971
What you’ll receive for the great work you provide:
PV14
Job Category
QualityFlex 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 does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices 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. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: accessibility@flex.com. Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.
