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Elk Grove Village, IL 60007
Oversee engagement and safety of production floor employees, processes for zero-defect quality, and operations for excellence in key performance metrics. Provide direction to implement, plan, develop, organize, and continuously improve production areas to maximize productivity and efficiencies, to minimize scrap and downtime, and to improve product quality and quality processes.
DUTIES AND RESPONSIBILITIES:
- Employee Engagement & Safety
- Track Key Safety Indicators.
- Oversee and develop shift supervisors and technicians including performance reviews.
- Follow all safety guidelines and assist as needed in other areas of manufacturing.
Zero Defect Quality
- Support quality tasks as per ISO-13485 Quality Program, including assisting in documenting work such as writing specifications for manufacturing or identifying and/or evaluating scientific test results
- Establish, document, verify, and maintain optimum processing parameters and establish upper and lower control limits for process monitoring system.
- Support both internally and externally driven RCCA (CAPA) and process improvement initiatives.
- Where applicable, participate in Design Reviews, including Technical Reviews and Feasibility Discussions, and Take lead in Failure Modes and Effects Analysis (FMEA) creation/updates.
- Manage Implementation and documentation of IQ, OQ, PQ and ensure timely and conclusive validations.
- Maintain quality standards as related to materials and update existing inspection plans and test methods
- Lead cross-functional teams in continuous quality improvement projects, in particular, in scrap reduction and identification and elimination of non-value-added activities
- Take lead in collection, review, analysis and trending of quality indicators for monthly and quarterly reviews
- P&L Ownership
- P&L Improvement through use of toolbox and strategic sourcing
- Track key performance indicators and uphold accountability systems.
- Analyze manufacturing processes and systems, identify areas for improvement, and work with strategic management in establishing plan for continued process improvement.
- Develop short and long-term plans for process improvements.
- Monitor and understand new technologies to improve quality and efficiency.
- Update standard operating procedures
- Develop preventive and predictive maintenance schedules and procedures.
- Be the technical authority on process monitoring and materials technology matters; draw from expertise of materials suppliers, processor, and other sources acting as a point of focus for direct or indirect input to solutions.
- Participate in the Internal Audit process and assist in addressing observations
- Participate in customer and regulatory body audits
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelor’s degree (Engineering field desired).
- 3 – 5 years related experience (required) in Medical Devices Industry (preferred).
- Ability to perform routine design and engineering tasks with some assistance.
- Solid understanding of engineering and mathematics principles.
- Able to command use of inspection and measuring instruments such as calipers, micrometers, and tensile strength testers
- Highly motivated, detail-oriented, eager to drive needed change in the organization
- Demonstrated use of strong analytical, problem solving, and teamwork skills in a leadership role
- Able to follow and to provide instructions in all formats: written, verbal, and electronic.
- Excellent time management, prioritization abilities, and strong project management skills
- Ability to develop, implement, and present strategies to gain support
- Strong analytical skills, with 80/20 mindset
- Ability to work with and manage complexity/change such that implementation is simplified
- Demonstrated ability to analyze data and make sound, enterprise-first, decisions
- Excellent interpersonal, communication, and presentation skills
- Ability to generate respect and trust from staff and external constituencies along with the ability to work collaboratively with colleagues and staff to create a results-driven, team-oriented, profitable environment
- Personally, driven and able to motivate others to excel
- Ability to use MS Office Tools such as Word, Excel, Project, Access and MiniTab®.
Physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
All your information will be kept confidential according to EEO guidelines.