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 Director of Quality will be based in Irving, TX. In this position, you will be responsible for developing, implementing and coordinating product quality assurance program(s) to prevent or eliminate defects in new or existing products through the development and management of people and processes.
Our Design Center is an ISO 13485 certified, FDA registered design and manufacturing center that focuses on medical equipment design for our customers.
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:
Provide oversight of the site Quality Engineering function. Ensures the comprehensive completion of design controls compliance, risk management, Design and Development quality plans, and IQ/OQ/PQ process validations, as well as test method validation, computer systems validations, clean rooms, facilities, and utilities.
Provide oversight of Quality Test Engineering function to ensure the product meets the requirements of design verification testing.
Maintain and improve Quality Management System in accordance with FDA Quality System Regulation, ISO 13485 requirements.
Establish plans to ensure site is continually prepared for FDA Inspections, Notified Body and Customer audits.
Function as Site Management Representative.
Report progress on quality issues and improvement programs to customers as required.
Maintain contact with customers to ensure their business needs are met or exceeded.
Review and Approve Quality Agreements and act as liaison with all clients on commercial quality topics.
Provide management oversight of Quality Management Systems functions, including Documentation Management, Engineering Change Control, Corrective Actions and Preventive Actions, Non-conforming Materials, Customer Compliant Handling, Internal Auditing, Quality Training, and Supplier Quality Management.
Responsible for conducting management reviews and generating and maintaining site quality system and product quality metrics / KOIs.
Manage Quality Engineering staff by providing coaching, counseling, planning, mentoring, etc. Establish measurable employee goals and perform appraisals through performance reviews
Identify, investigate, properly document, and implement quality improvements and initiatives for both product and process; coach others in doing the same.
Provide oversight, training, and direct review of the generation of quality documents and records related to implementation and/or compliance with medical regulations (i.e. CFR 820, ISO 13495, etc.)
Lead NPI facing Quality Engineering function.
Hire, train and deploy technically competent Quality Engineers and other quality professionals to provide quality-based deliverables to the Design Control process and on-going operations, including but not limited to the following: Master Validation Plans, dFMEA, pFMEA, inspection plans, critical component evaluations, product and process validations, etc.
Ensure full participation of Quality Engineering with NPD and NPI functions.
Ensure design compliance with applicable medical device standards.
Continuously improve product cost, quality, delivery and service levels.
Manage resources among competing departments, customers, and projects.
Contribute to supplier development activities via close association with Component Engineering Director.
Here is some of what you’ll need (required):
10-15 years of QA/QC/RA experience in medical devices or invitro-diagnostic devices (IVD).
Bachelor’s degree in Engineering, Science, or equivalent technical discipline.
Minimum 5 years’ experience as site level Quality Director.
Experience in Medical Device Design and Development, Quality Engineering, process validation of high volume / automated manufacturing lines, molding operations, and sterilization methods.
Extensive understanding and application of FDA 21 CFR Part 820 (including design controls) and all associated regulations and guidance related to medical device manufacturing and ISO13485-2016 compliance.
Experience managing FDA site inspections and teaming with customer and business partners to start up new medical product manufacturing projects.
Strong technical analytical skills including FMEA, statistical methods, and Six Sigma techniques.
Highly proficient in Microsoft Word, Excel, and Project programs.
Demonstrated skills in project management and ability to train others to lead projects.
Proven experience achieving results through others and managing a wide range of individuals is required.
Here are a few of our preferred experiences:
Experience working under clean room and environmental control conditions. In addition, experience in one or more sterilization technologies and release of sterile product is preferred.
Quality performance track record in a medium to large-scale medical device product development and manufacturing site is preferable.
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
QualityFlex 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: firstname.lastname@example.org. 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.
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