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 Buffalo Grove, IL. and will primarily 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.
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:
Surveys and evaluates future and current vendors.
Prepares and implements QA Policies and Procedures.
Reviews discrepancy reports and implements corrective actions.
Reports progress to customers as required. Maintains contact with customers to ensure their business needs are met or exceeded.
Conducts presentations to staff as required.
Establishes QA objectives and creates plan of action.
Cooperates with top management personnel in formulating and establishing company policies, operating procedures and goals.
Evaluates content of reports from product assurance program department heads and confers with top management in formulating fiscal budget for product assurance program.
Confers with engineering about quality assurance of new products designed and manufactured.
Reviews technical publications, articles and abstract to stay abreast of technical developments in industry.
Implement appropriate HR strategies and actions to recruit and retain a qualified and motivated workforce.
Makes decisions for the function and the site. Decisions may affect site.
Recognizes and develops talent as a key element of executing operational business plans. Ensures Flex values are part of site work life. Provides strategic leadership for the function and the site
While performing the duties of this job, the employee is occasionally exposed to work that requires repetitive motion. The noise level in the work environment is usually moderate.
While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to sit. Specific vision abilities required by this job include close vision
Here is some of what you’ll need (required):
Experience with injection molding for medical device and medical device manufactures
Extensive understanding and application of FDA 21 CFR Part 820 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 helpful.
experience working under clean room conditions, sterilization and environmental control conditions preferable.
Demonstrates mastery of functional knowledge in relation to other functions and a complete understanding of the function and those of related businesses.
Must have knowledge of relevant regulatory standards and applicable regulations.
Demonstrated skills in project management and ability to train others to lead projects.
Ability to read, analyze, and interpret the most complex documents.
Ability to respond effectively to the most sensitive inquiries or complaints.
Ability to write speeches and articles using original or innovative techniques or style.
Ability to make effective and persuasive speeches and presentations on controversial or complex topics to top management, public groups, and/or boards of directors.
Ability to work with mathematical concepts such as probability and statistical inference to practical situations.
Ability to think strategically, define problems, collect data, establish facts and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Here are a few of our preferred experiences:
Bilingual English/Spanish preferred
International travel may be required 2-4 times per year
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 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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