Operations Manager

Lubrizol Corporation•Corona, CA

92d•$125,000 - $165,000•Onsite

About The Position

The Operations Manager is a key leadership role responsible for managing an extruded thermoplastic medical device components and finished device assembly contract manufacturing operation. This position will supervise a manufacturing and warehouse organization of 130+ employees, including departmental supervisors, leads, extrusion technicians, operators/assemblers, material handlers, and receiving/shipping personnel. This position is responsible for monitoring the daily production and achieving production output, schedule attainment, quality, and productivity targets. They are responsible for ensuring that all operations are done in adherence to Good Manufacturing Practices (cGMP’s), Good Documentation Practices (GDPs) and other internal QMS requirements, while ensuring that all work performed meets Lubrizol safety policies and expectations. Actively identifies operational issues and constraints that prevent Operations department from meeting their goals and develops effective solutions to address those.

Requirements

Bachelors’ Degree in relatable field.
5+ years of experience in manufacturing or operations management in a medical devices or pharmaceutical production facility.
Experience leading large 24/7 production organizations:
Experience formulating and driving KPIs to meet corporate goals and objectives.
Experience driving Continuous Improvement and change across large organizations.
Strong familiarity with ISO13485 and FDA 21 CFR Part 820 GMP requirements.
Ability to quickly analyze and problem-solve various production issues with a bias-to-action to implement effective solutions.
Strong computer software and familiarity with ERP systems.
Ability to multi-task and work well under pressure.
Experience in presenting complicated data and information to diverse business professional audiences.

Nice To Haves

Degree in Engineering or Operations Management.
Experience with thermoplastic extrusion operations and medical device assembly is strongly preferred.
Knowledge of lean manufacturing and fundamental six sigma statistical concepts.
Strong experience developing and managing manufacturing teams to performance metrics.
Ability to work in a cleanroom environment, both ISO class 7 and class 8.
Familiarity with standard cost models and capacity resource planning methodologies.
Flexible to change and possess a high level of integrity with an “All In - Can Do Attitude” with employees across all levels, departments and or roles and responsibilities.
Ability to receive and provide instructions in a positive manner.

Responsibilities

Lead the plant’s manufacturing organization to ensure that product is built in conformance to specifications and quality requirements and is delivered in full to customer ordered quantities and committed delivery dates.
Continually assess and manage production capacity to ensure that manufacturing demand can be met both in the short-term to meet weekly production schedules and in the long-term to meet annual demand forecasts and annual operating plan.
Develop and manage annual headcount budget plan and operational expense budgets.
Collaborate with Supply Chain to analyze and finalize weekly production schedules to ensure they are attainable based on capacity and resource constraints.
Monitor the execution of job orders against the production schedule for timely delivery and report risks and issues to cross-functional partners and Management as required.
Investigate any and all production control problems, analyze root causes, and derive solutions.
Ensure that line and departmental goals are clearly set and communicated to all personnel and that all production escalations are completed in accordance with policy.
Manage production personnel performance against clearly defined objectives and expectations based on plant’s KPIs and targets and through effective and timely communication.
Develop and implement continuous improvement initiatives to improve efficiency of production set-ups and execution in order to reduce overall manufacturing costs and improve delivery performance.
Manage and minimize work order variances to ensure standard cost targets are met for material usage, labor times, yields, and overtime premium pay. Ensures that any erroneous data entries leading to variance are corrected and minimized.
Work with cross-functional departments in identifying and resolving production problems that may arise.
Determine equipment, material and manpower requirements for each job order to execute an organized schedule attainment strategy.
Investigates internal product and process non-conformances and customer complaints through reporting, participating in Material Review Board (MRB) meetings and supporting team activities that are focused on recommendations of permanent manufacturing improvements to correct and prevent recurrences.
Ensure that regular cycle counts are conducted in cooperation with Supply Chain per company policy to minimize inventory discrepancies and negative impact to production execution.
Manages site’s MRO supplies kanban system to ensure that required production supplies are always in stock to prevent negative impact to production execution.
Oversee finished goods inventory levels to effectively use working capital and minimize inventory write-offs.
Plan, monitor, and report real time material consumption, labor hours, and WIP movement in the system.
Review and approve as required change orders and execute them appropriately.
Team up with New Product Development team to ensure design-for-manufacturing considerations are incorporated and that required documentation for commercial launch is complete and in place to facilitate a smooth transition of NPD product to production.
Ensure that operations staff follow all company policies and safety procedures, include requirements for working in a controlled environment.
Develop positive relationships with all staff in order to meet and align to plant operational goals.
Monitor and improve as needed manufacturing operator training program to ensure staff follow standard work procedures and meet operational performance metrics.
Implement manufacturing cross-training program to provide optimal production flexibility while promoting career development for staff.
Maintains and reinforces standards for housekeeping and safety across the plant.
Create succession plans and development plans to improve effectiveness of staff.