The Senior Director of Quality Engineering – Medical will be based in Buffalo Grove, IL or Austin, TX. The Senior Director will be responsible for developing, implementing, and coordinating product quality engineering assurance program(s), procedures, and methods to detect, solve, and prevent or eliminate defects in new or existing products and in the manufacturing processes. The ideal candidate will provide strategic leadership for global quality engineering functions related to design and development, design transfer/new product introduction, quality engineering, Sterilization/Microbiology, and continuous product quality improvement. This position requires extensive interaction and strong liaison activities with internal management teams as well as externally with customers and regulatory agencies.
This position will require approximately 50% travel.
We are looking for someone who demonstrates:
- Intense collaboration
- 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…
- Define quality engineering strategies and objectives for the design and manufacturing processes in the Flex global network.
- Apply six-sigma, LEAN, and project management principles.
- Provide Subject Matter Expertise in quality engineering, DOEs, process validation, statistical methods, computer systems and software validation, TMV/MSA, sterilization validations, biological monitoring, design controls, and risk management / pFMEA.
- Assist in the resolution of product quality issues, providing decisions and judgment pertaining to risk acceptability.
- Must be a hands-on leader and practical thinker, able to identify and devise realizable solutions and roll-up sleeves to get things done.
- Manage the corporate quality engineering team and guides the organization for strategic and tactical issues. Establish Quality Engineering objectives and creates plan of actions.
- Act as the main Flex Compliance representative for Flex New Product Introduction (NPI) organization. Confer with development engineering / program management about quality aspects of new products designed and manufactured.
- Establish the specific training for the engineering quality area to detect, solve and prevent problems in the manufacturing processes.
- Review 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.
- Participate in internal and external quality audits with customers, notified bodies, and regulatory agencies.
Here is some of what you'll need (required)…
- A bachelor's degree in an engineering or related field
- Minimum 8 years of quality or program management experience in manufacturing
- Minimum 4 years of experience progressing quality leadership in medical device with strong product experience in the medical device industry
- Experience in process validation, test method validation, software validation
- Experience implementing design FMEAs, process FMEAs, and Control Plans to support process validations
- NPI and design/manufacturing transfer from diverse medical device technologies, such as plastic injection molding, plastic extrusion, PCBA, electromechanical assemblies, sterilization, etc.
- Must have knowledge of relevant regulatory standards and applicable regulations, including, but not limited to: FDA QSR, ISO13485, European Medical Device Directive/Regulation, JPAL
- Demonstrated knowledge in project management, statistical methods, process, environmental, and test method validations, design and development controls, software validation, risk management
Here are a few of our preferred experiences…
- A Master's or MBA degree preferred
- Considerable personal experience presenting, interacting, and building effective relationships with internal management teams, customers, and regulatory agencies
- Ability to effectively implement continual improvement to increase efficiency and promote simplification while maintaining or increasing compliance
Here are a few examples of what you'll get for the great work you provide…
- Full range of medical benefits, dental, vision
- Life Insurance
- Matching 401K
- Tuition Reimbursement
- Employee discounts at local retailers
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