This individual is needed to help define and build Operational Excellence in a growing medical device manufacturing company. This individual oversees the Reagent Manufacturing Continuous Improvement Team as well as the Manufacturing Reliability team on the Reagent Manufacturing floor. Key responsibilities include:
- Development and organization of continuous improvement efforts in Reagent Manufacturing.
- Standardization, implementation and monitoring of continuous improvement tools and methodologies including Lean, 6S, Red Tag, Kaizen, and problem solving.
- Utilizing manufacturing data to develop and track KPIs for each work center in Reagent Manufacturing.
- Leverage manufacturing data to coordinate troubleshooting efforts that arise in reagent Manufacturing.
This position reports to the Senior Director of Reagent Manufacturing Support and interacts with senior members of the Reagent Manufacturing Operations, Engineering, QA, Materials Management, Facilities teams as well as other business units as needed.
- Perform all work in compliance with company policy and within the guidelines of its Quality System.
- Works closely with operations management and operations support teams (including, but not limited to, Maintenance, Engineering, Quality Assurance, Safety and Technology Transfer) to develop relevant manufacturing KPIs as well as tactics that help operations achieve those KPIs.
- Works closely with the operations management team as well as the appropriate business systems to generate standardized reporting for operational metrics that will be used in Management Review as well as drive Continuous Improvement.
- Review personnel performance and compensation. Responsible for all hiring decisions within the team including obtaining new job approvals.
- Develop and monitor manufacturing data related to product reliability. Work through the manufacturing support teams to review data and proactively respond to identified trends.
- Leveraging manufacturing data, coordinate trouble shooting efforts for larger scale product non-conformances and CAPAs.
- Organize and lead department safety meetings.
- Present CI metrics at Management Review meetings.
- Trains team on methods of continuous improvement practices including Lean, 6S and Kaizen.
- Responsible for standardizing 6S, Red Tag, and other administrative policies/guidelines in the Reagent Manufacturing spaces.
- Point of contact for Continuous Improvement initiatives on the Reagent Manufacturing floor.
- Interface with counter parts at other Biomerieux sites to collaborate on best practices.
- Responsible for creating and maintaining the Value Stream Map of Reagent Manufacturing.
- Promotes QSR compliance in all assigned tasks.
- Serves as the area representative for the Safety and Security team, BERT teams, and other facilities or safety requirements. Acts as liaison to implement policies and procedures from the facilities department to the departments occupying the manufacturing spaces.
- Manages best practices for operational excellence within the manufacturing division.
- Other duties as assigned.
Training and Education:
- A degree in a Life Science, Engineering or Manufacturing/Business Operations.
- 4 years related experience will be accepted in lieu of degree
- Certifications in Lean, Six Sigma, and/or APICS. Minimum of green belt or equivalent. Black belt is preferred.
- Minimum of 5 years in an FDA/ISO manufacturing environment with a minimum of 3 years in a leadership role
- Knowledge of and experience implementing continuous improvement principles.
- Knowledge of real time PCR is preferred.
- Experience in Industry and Knowledge of GMP/QSR/ISO is also preferred.
- Experience in PCR based medical device-systems
- Experience in high throughput manufacturing
- Experience in data science/statistical analysis
- Experience making improvements in an automated manufacturing environment
Skills and Qualifications:
- Well-developed managerial skills including: Computer literacy in database, spreadsheet, projectand word processing software. Ability to write reports and manufacturing procedures. Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to organize, lead and evaluate the work of other personnel required. Ability to develop, coordinate and implement multi-level individual and team-based tasks. Well-developed interpersonal communication skills.
- Comprehensive understanding of industry regulations and cGMP compliance
- Demonstrated understanding of Kaizen, 5s, and Lean Manufacturing principles
- Statistical process control
- Strong problem-solving skills and attention to detail
- Demonstrate high-level of professional and business judgment when communicating with cross-functional teams and others at all levels of the organization
- Demonstrated organizational and mentoring skills.
- Ability to work independently with minimal supervision.
- Ability to manage numerous priorities simultaneously
- Ability to shift priorities to meet required deadlines
- Effectively communicate issues cross-functionally in a timely manner
- Must be proficient with Microsoft Office applications, including Word, Excel and Power Point.
- Design of experiments
- Six Sigma or CQE certification
- Lean certification
- Project Leadership
- Training and development