Senior Director of Quality Systems - Medical Devices
August 24, 2018
Buffalo Grove, Illinois
Full Time - Experienced
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 Systems – Medical Devices will be based in Buffalo Grove (Chicago, IL), Plano (Dallas, TX) or San Diego, CA and will require 25% travel. The Senior Director of Quality Systems – Medical Devices is responsible for (1) providing strategic leadership in global quality activities to ensure continual compliance to US / international regulations and standards, (2) lead efforts to implement best in class quality systems procedures and practices, (3) provide development and management of people and processes. 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:
Prepares and implements corporate quality management systems procedures and policies to ensure continual compliance with applicable US / international regulations and standards.
Promote the company-wide understanding of the QMS. Ensures that company employees are trained on applicable procedures, regulations, and standards
Serves as business owner for QMS and document control software systems.
Reviewing and assessing the suitability and effectiveness of the quality system, including trending and performing data analysis
Develop and review quality system and product quality related metrics with senior management
Help drive a culture of quality and continuous improvement throughout the organization
Ensures sites have implemented effective compliance programs and are prepared for regulatory inspections, notified body audits, etc.
Leads preparation and management of external regulatory inspection activities. Interface with regulatory agencies (FDA), notified bodies (TUV), other competent authorities. Responsible for addressing audit findings, responses, and corrective and preventative actions.
Oversight of corporate internal and external audit programs and drive continuous improvements to corporate and local quality systems.
Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.?
Perform other duties as assigned by supervisor.
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 8-10 years of progressing quality leadership experience. A Master’s or MBA degree is preferred.
5-7 years minimum of manager or director level quality engineering experience
Prior global quality leadership experience; Ability to work across cultures/poles/sites
Must have multi-site leadership experience: Experience implementing single quality management systems across multiple regulated sites.
Proven track record of successful FDA / regulatory inspections/audits.
Here are a few of our preferred experiences…
Experience managing or implementing state of the art Quality Management System software application tools.
Strong track record of deploying quality systems and product quality metrics, and data analysis.
Ability to effectively implement continual improvement to increase efficiency and promote simplification while maintaining or increasing compliance.
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
Strategic thinking for deployment of software tools for quality systems management – need to be able understand how SW tools work, how they are integrated with the Quality procedures, what is required to maintain, sustain & validate the systems.
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: WD060563
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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