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 at our Buffalo Grove (IL) site, which is our state of the art hub for medical device manufacturing in the US and also one of our quickest growing sites globally. The Director of Quality will provide overall management of the manufacturing site’s quality operations, quality engineering, and compliance functions. You will oversee significant improvement in site quality culture and to drive towards a world class operation. The role will be responsible for implementing and coordinating product quality assurance improvement program(s) to prevent or eliminate defects in new or existing products through the development and management of people and processes. It will allow the person hired to make a difference and put your own stamp on things and build a world class quality organization.
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:
Provide oversight of site Quality Engineering functions. Ensures the comprehensive completion of risk management, process quality control plans, and IQ/OQ/PQ process validations, as well as validations of test method validation, computer systems validations, clean rooms, facilities, and utilities.
Provide oversight of Quality Operations, including Quality Assurance and Quality Control functions, incoming in-process, and Final quality inspections, and quality release of product DHR records.
Champion and serve as a role model in embracing zero defect quality concepts and culture
Maintain and improve Quality Management System in accordance with FDA Quality System Regulation, ISO 13485 requirements.
Establishes plans to ensure site is continually prepared for FDA Inspections, Notified Body and Customer audits.
Functions as site Management Representative.
Report progress on quality issues and improvement programs to customers as required. Maintains contact with customers to ensure their business needs are met or exceeded.
Review and Approve Quality Agreements and act as liaison with all clients on commercial quality topics.
Provide management oversight of Quality Management Systems functions, including Documentation Management, Engineering Change Control, Corrective Actions and Preventive Actions, Non-conforming Materials, Customer Compliant Handling, Internal Auditing, Quality Training, and Supplier Quality Management.
Responsible for conducting management reviews and generating and maintaining site quality system and product quality metrics / KOIs.
Manage Quality Assurance staff by providing coaching, counseling, planning, mentoring, etc. Establish measurable employee goals and perform appraisal through performance reviews
Here is some of what you’ll need (required):
10-15 years of QA/QC/RA experience in medical devices or invitro-diagnostic devices (IVD).
Bachelor’s degree in engineering, science, or equivalent technical discipline.
Minimum 5 years’ experience as site level Quality manager or director
Experience in Quality Engineering, process validation of high volume / automated manufacturing lines, molding operations, and e-beam sterilization methods highly preferred.
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.
Excellent judgment and decision-making capability – both technical and compliance.
Experience working under clean room conditions, sterilization and environmental control conditions preferable. In addition, experience in one or more sterilization technology and release of sterile product is preferred.
Demonstrated skills in project management and ability to train others to lead projects.
Integrity, judgment, and the ability to hold one’s ground under pressure.
Here are a few of our preferred experiences:
Ability to work in a multinational, multicultural and highly matrix environment.
Strong product quality focus
Ability to think strategically when problem-solving
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 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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