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 Senior Director of Quality Engineering will be based in Buffalo Grove, IL, Plano, TX, or San Diego, CA but will require approximately 50% travel. The position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies.
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…
Define quality engineering strategies and objectives for the design and manufacturing processes in the Flex global network.
Apply six-sigma, LEAN, and project management principles
Provide Subject Matter Expertise in quality engineering, DOEs, process validation, statistical methods, software validation, TMV/MSA, sterilization validations, design controls, and risk management / FMEA.
Must be a hands-on leader and practical thinker, able to identify and devise realizable solutions and roll-up sleeves to get things done.
Manages the corporate quality engineering team and guides the organization for strategic and tactical issues. Establishes Quality Engineering objectives and creates the plan of actions.
Acts as the main Flex Compliance representative for Flex New Product Introduction (NPI) organization. Confers with development engineering / program management about quality aspects of new products designed and manufactured.
Establish the specific training for the engineering quality area to detect, solve and prevent problems in the manufacturing processes.
Reviews technical publications, articles and abstract to stay abreast of technical developments in the industry.
Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.
Here is some of what you’ll need (required)…
Typically requires a bachelor’s degree in a related field or equivalent experience and training plus a minimum of 8 years of management experience. A Master’s or MBA degree is preferred.
Must have 4+ years of progressing quality leadership in medical device and have a diverse amount of product experience in this industry
Must have knowledge of relevant regulatory standards and applicable regulations, including, but not limited to, expertise in FDA QSR, ISO13485, European Medical Device Directive/Regulation, JPAL
Proven track record of successful FDA / regulatory inspections/audits.
Experience implementing a single quality management systems across multiple regulated sites.
Experience managing or implementing state of the art Quality Management System software application tools.
Here are a few of our preferred experiences…
Ability to think strategically, define problems, collect data, establish facts and draw valid conclusions.
Considerable personal experience presenting, interacting, and building effective relationships with internal management teams, customers, and regulatory agencies. Strong communication and presentation skills (articulate and persuasive)
Ability to effectively implement continual improvement to increase efficiency and promote simplification while maintaining or increasing compliance.
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.
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Internal Number: WD044518
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.
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