At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose - to make great products that create value and improve people’s lives.
Job Summary
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to Engineer - Quality add located in Chennai.
What a Typical day looks like :
Responsible for coordinating new manufacturing line specification, qualification, validation and ramp to high volume following all cGMP and ISO 13485 protocols and standards.
To work with R&D team, Pilot equipment suppliers & engineering team to validation Pilot
Responsible for Pilot line User requirement Specification with edits as Project progresses
Responsible for preparing Qualification & validation documents(DQ,IQ,OQ,PQ,FQ)
Assist with core team for Quality documentation URS, PFMEA, Control Plan, Risk Mitigation Plans
Verify the validation activities as subject matter expert to ensure that processes fully comply with ISO and FDA regulation requirements
Works with manufacturing engineering to address quality issues
Follow up on CAPA, (Corrective Actions Preventive Actions) NCRs (Non-Conformance Report) and ECRs (Engineering Change Requests); participate in root cause analysis.
The experience we’re looking to add to our team:
Knowledge on Medical standards (ISO 13485 , FDA, EU MDR)
Certified ISO 9001: 2008 auditor. TS certification and other certifications an added advantage
Experience in In-process , Supplier Quality and Customer Quality activities
Knowledge and experience in Quality Tools , Problem solving tools , Customer Complaint analysis
- Sound knowledge on FMEA and Control Plan and able to work independently in these areas
- New Product / Project Management
- Knowledge and experience in preparation of various Quality reports.
- Knowledge and experience in preparing the Quality plan for the Reports and other services.
- Train new and existing team members on an ongoing basis on relevant tools or topics.
- Knowledge and experience in Lean and Kaizen projects
Here are a few of our preferred experience:
- Minimum 3-5 years of relevant experience
- Experience in Medical Products Manufacturing Industry.
What you’ll get for the great work you provide:
Health Insurance
PTO
AS04
Job Category
Quality
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 recruitment process. Please advise us of any accommodations you may need by e-mailing: accessibility@flex.com.
