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 a glimpse of what you’ll do:
Collaborates with corporate leaders, site representatives, and company clientele to increase synergy and efficiency with microbiological & sterilization implementations. Keep management personnel informed of all relevant events impacting global operations and performances.
Work with Flex Sites on their Site Ownership portions for microbiology, sterilization, and associated packaging expertise and execution.
Ensures Flex is properly equipped with appropriate calibrated state-of-the-art equipment design for adequate throughput and full global compliance, and/or has the services that can meet these requirements.
Is responsible for promoting the analyzing & trending of all microbiological test data to include drafting and preparation of reports, presentations and formal communications as to the current state of control for the manufacturing areas. Helps drive corrective actions when needed.
Provides guidance and mentoring in the development of test protocol design for efficient implementation of validation for test methods, cleaning methods, equipment and instruments used in testing or monitoring of the cGMP environment in support of ongoing production activities.
Is a Flex Representative on industry consortiums and regulatory committees.
Thinks strategically for development and improvements to current monitoring and testing programs, for cGMP production and test methods to meet the requirements for high throughput and full global compliance.
Plans and coordinates training what leads to the development of cross-trained, self-directed work teams in line with total quality management concepts. Is accountable to ensure development of Flex Team Members to ensure they are adequately trained, mentored and motivated, as well as adhere to quality performance standards.
Here is some of what you’ll need (required):
Minimum Bachelor’s degree in engineering or life sciences with 10+years of direct experience. Emphasis (major) in Microbiology is preferred. Or, master’s degree in engineering or life sciences with 7+years of direct experience. Emphasis (major) in Microbiology is preferred.
Experience with sterilization validation methods and procedures and microbial/bioburden monitoring. Knowledge of Gamma, ETO, E-Beam and other sterilization methods.
Experience leading validation of cleanrooms.
Knowledge of ASTM and ISTA packaging test methods.
Minimum 5 years of progressive supervisory-managerial experience in cGMP environment.
Experience in a regulated industry (such as medical device, pharmaceutical) where cGMP quality control requirements were key. Knowledge of cGMP regulations and latest validation guidelines and related standards.
Able to understand and scientifically interpret data utilizing analytic skills and practical experience.
Team leadership skills requiring good communications essential to building and maintaining high performance teams.
Able to manage multiple changing priorities while maintaining company efficiencies with compliance. Demonstrates project ownership
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: 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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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: WD063932
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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