- Lead team of 190+ people in a 24/5 IVD medical device production environment.
- Oversee day to day operations of the manufacturing department that include scheduling, production planning and resource allocation.
- Lead the team by example and maintain moral of the work force and address personnel issues.
- Communicate with Shift Managers to ensure a cohesive product flow.
- Keep Management informed of all issues that could affect or interrupt production flow.
- Monitor production processes to ensure efficiency, productivity and profitability targets and consistently met or exceeded.
- Develop and adhere to departmental budget, including OPEX, headcount, and CAPEX
- Work closely with cross-functional teams such as HSE, HR, Line Maintenance, Engineering, Supply Chain, Quality Control and Quality Assurance.
- Ability to adapt and work under pressure to meet deliverables in a fast paced and dynamic environment.
- Strive to reduce expenses and increase productivity.
- Excellent interpersonal and communication skills that foster collaboration with cross-functional teams at all levels in the business.
- Ensure compliance with all applicable regulations, industry standards, quality management systems and ISO certifications.
- Strong understanding of quality management systems in a regulated industry (FDA).
- Be aware of emerging industry trends, technological advancements and manufacturing best practices. Seek opportunities to leverage technologies and methodologies that can improve manufacturing processes.
- Develop and implement ideas for process improvements.
- Collaborate with other supporting departments and team members.
- Sustain product quality and cost objectives.
- Problem solving and decision-making experience based upon use of data analysis of complex issues and objectives.
- Demonstrated leadership and management background with the ability to motivate and inspire a diverse team.
- Optimize production capacity and efficiency.
- Define and maintain production reports and statistics.
- In depth knowledge of manufacturing principles, processes and technologies including Lean Manufacturing, Six Sigma and Continuous Improvement methodology.
- Experience in reporting on key production metrics (KPIs).
- Develop and execute manufacturing strategies that align with the company's goals and objectives and achieve budget goals.
- Proficient use of manufacturing software systems such as MRP, MES, SPC and Compliance Tools.
- Establish ambitious production goals.
- Personally champion the continuous improvement of the safety culture and lead by example.
- Lead recruitment, coaching, enforcing company policies, conflict resolution and disciplinary actions.
- Knowledgeable of health and safety regulations applicable to the manufacturing industry. Education, Skills, & Experience:
- Bachelor's degree in engineering, business administration or related field with 7 years of experience in manufacturing/production operations. Master's degree preferred.In lieu of a degree, high school diploma/GED with 11 years of experience in manufacturing/production operations
- Successfully managing large-scale manufacturing operations, preferably within a regulated industry.
- Implementing lean manufacturing principles and driving continuous improvement.
- Knowledge of manufacturing processes, technologies, and best practices.
- Managing and developing a high performing manufacturing team.
- Ability to clearly communicate complex topics and ideas and champion solutions to successful completion.
- Project management skills with the ability to prioritize and manage multiple projects simultaneously.
- Developing and implementing manufacturing strategies that drive operational excellence.
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Associate Director, Manufacturing - Hazelwood, United States - BioFire Diagnostics, LLC
Description
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Description
Position Summary:
The primary purpose of this position is to direct Reagents Manufacturing at the St Louis Operations site to ensure that disposable diagnostic product is manufactured per company and Regulatory requirements. This requires the ability to direct the activities of multiple shifts, develop teamwork between departments to ensure consistent product flow, maintain a safety and quality-oriented culture by addressing identified concerns and proactively seeking improvement opportunities. This position will be required to provide technical expertise and quality support through implementation of projects and continuous improvement activities.
Primary Responsibilities:
