Job Summary:
The Senior Production Manager is responsible for strategically managing personnel, equipment, materials, processes, and the production environment to ensure the efficient achievement of production plans and drive enhanced productivity. In light of the company's ongoing expansion, this role requires a high degree of adaptability to evolving needs and the proactive identification and resolution of potential challenges to support organizational growth.
Essential Duties and Responsibilities:
Include the following. Other duties may be assigned.
- Ensures full production operation compliance with company policies and regulatory requirements, including the seamless transfer of products by closely imitating processes, quality standards, and best practices from the original site to maintain consistency and efficiency.
- Develops and implements strategic production plans to meet company objectives and output targets.
- Reviews production orders and schedules to guarantee the timely production of qualified products.
- Leads teams in analyzing production variances and implementing effective corrective and preventive actions.
- Champions Lean and Kaizen initiatives, leveraging methodologies such as Value Stream Mapping (VSM) and cell line design to optimize processes, improve efficiency, reduce scrap, eliminate waste, and effectively manage labor hours.
- Monitors quality control processes and resolves production quality issues, ensuring adherence to ISO13485, and FDA regulations.
- Manages production labor and fosters a positive work environment, overseeing and directing 5S and EHS (Environment, Health, and Safety) activities within the production department.
- Trains and motivates production teams, ensuring the timely completion of work and facilitating continuous skill development.
- Participates in management review meetings and collaborates with other departments to achieve overall production goals.
- Drives departmental performance by monitoring and improving key production and quality metrics, including output yield (First Pass Yield (FPY), Final Yield (FY)), Efficiency, Cycle Time, production schedule On-Time Delivery (OTD), daily fill rates, and cost control.
- Supports process improvements, qualifications, and validations, including specifications for equipment and materials.
- Ensures comprehensive and accurate documentation of all production processes.
- Verifies the effectiveness and efficiency of all production-owned procedures, ensuring actual practices align with requirements.
- Coordinates and communicates effectively with other departments to support seamless production operations.
- Performs other duties as assigned by the supervisor.
Education/Experience and Qualifications:
- Bachelor's degree or higher, coupled with a minimum of 8 years of relevant professional experience within the medical device industry.
- Possesses strong analytical capabilities, a solution-driven and process-oriented mindset, and is highly organized and structured in approach.
- Exhibits a focus on continuous improvement, is self-directed, and consistently delivers results.
- Proficient in conducting failure and root cause analysis and implementing effective corrective actions
- Knowledge of Lean manufacturing and Six Sigma methodologies is advantageous.
- Demonstrates excellent communication and production management abilities.
- Must have familiarity with medical device standards and regulations, including ISO 13485 and FDA 21 CFR.
- Strong leadership, interpersonal, and influential skills, with the ability to drive change management
- Ability to work under pressure in a fast-paced and dynamic environment
- English proficiency with effective communication skills
