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 Quality Compliance Manager – Microbiology and Sterilization will be based in Buffalo Grove, IL and will require approximately 40% travel, both domestic as well as international. The main focus of the role will be to support the continued growth of the global medical business at Flex which includes:
• Managing and prioritizing the functioning of site & supplier labs with the Flex Medical segment to provide for the timely, compliant and accurate testing of materials, in-process testing, finished product testing, as well as environment and critical system monitoring. This is in support of finished product release to ensure all aspects of production meet USA and regulatory quality requirements. • Acting as a Corporate Leader in establishing and insuring packaging and sterilization validations, including cleaning methods (development & training) and associated validations. • Acting as a corporate Subject Matter Expert for compendial testing and other laboratory methodology in support of troubleshooting operational issues in development of product strategies, production, and laboratory environments. • Being knowledgeable with state-of-the-art technologies and instrumentation and implementing new technologies in the cGMP environment in support of ongoing production activities with Flex global sites.
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 some of what you’ll need (required):
BS in engineering or life sciences with 10+ years of direct experience. Emphasis (major) in Microbiology is preferred. Alternatively, master’s degree in engineering or life sciences with 7+years of direct experience.
Experience with sterilization validation methods and procedures and microbial/bioburden monitoring. Strong Knowledge of Gamma, ETO, E-Beam and other sterilization methods.
Experience leading validation of cleanrooms and applications, including microbial count testing, interfacing with external labs dealing with sterile testing and methods testing
Able to understand and scientifically interpret data utilizing analytic skills and practical experience.
Knowledge of cGMP regulations and latest validation guidelines and related standards with experience in a regulated industry (such as medical device, pharmaceutical), including knowledge of ISO 11737, ISO 14644, ASTM/ISTA packaging test methods, and related microbiological, clean room, and sterilization standards.
Project leadership skills requiring good communications essential to building, educating supporting cross functional teams.
Here are a few of our preferred experiences:
ASQ or relevant certifications
Successful candidate will need to possess a strong combination of technical knowledge as well as hands-on experience with working protocols, test methods, microbial work, extractions, and external lab work
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 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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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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