Flex is a leading sketch-to-scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help make the world Live Smarter™, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets. For more information please visit our careers page at www.flex.com.
Industry: Electrical / Electronic Manufacturing
Type: Public Company
Headquarters: 2 Changi South Lane, Singapore, 486123
The CAPA Coordinator will be based in Buffalo Grove, Illinois. In this position, you will be responsible for Regulatory and Quality Systems Internal Audits, support the organization to conform and comply with regulations, internal policies, directives and procedures to achieve and exceed the quality objectives expected by the customer and the organization.
We are looking for someone who demonstrates:
Passionate customer focus
Thoughtful, fast, disciplined execution
Tenacious commitment to continuous improvement
Relentless drive to win
Here is a glimpse of what you’ll do:
Assure the conformance of all organization's regulatory and quality systems requirements.
Perform internal audits to verify compliance and conformance to all regulatory and quality systems requirements.
Engage in External Audit Processes (Customers', Regulatory, Government Agencies, etc.).
Provide support to any area that requires help to implement regulatory and quality requirements into their processes.
Develop training programs for internal users in subjects related to Regulations or Quality Systems.
Prepare the Audit Plan and related Audit Checklists.
Create audit reports that identify any Non-Conformance or Opportunities for Improvement found during the audit process.
Document all audit findings and request the corrective / preventive actions needed.
Follow up on internal and external corrective actions to ensure timely implementation and validate their effectives.
Here is some of what you’ll need (required):
Understanding and comprehension of ISO 13485 and FDA requirements.
Experience implementing and maintaining quality systems.
Ability to write reports, conduct internal audits and support with external quality system audits.
Experienced in corrective actions and preventive actions.
Bachelor’s Degree in related field or equivalent experience.
Here are a few examples of what you’ll get for the great work you provide:
Full range of medical benefits, dental, vision
Employee discounts at local retailers
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 on the basis of: 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 in order to express interest in a position by e-mailing: email@example.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.
The information we collect:
We may collect personal information that you choose to submit to us through the Website or otherwise provide to us. This may include your contact details; information provided in online questionnaires, feedback forms, or applications for employment; and information you provide such as CV/Resume. We will use your information for legitimate business purposes such as responding to comments or queries or answering questions; progressing applications for employment; allowing you to choose to share web content with others or; where you represent one of our customers or suppliers, administering the business relationship with that customer or supplier.
Internal Number: WD066055
Flex is a leading Sketch-to-Scale™ solutions company that designs and builds intelligent products for a connected world. With more than 200,000 professionals across 30 countries and a promise to help the world Live smarter, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets.
We believe in a brighter tomorrow and what people can do when our lives are connected. That’s why every day we set out to do one thing–-create a smarter, more connected world. Our focus is developing and empowering talented people to deliver on their potential, providing employees with a healthy, safe and secure workplace.
Join the revolution: