Cleanroom Lead @ Harlan Medical Systems

Cleanroom Lead

Department: Manufacturing

Status: Hourly

Reports To: Director

Direct Reports: Coating Technicians

Position Purpose(s):

The Cleanroom Lead is responsible for providing leadership to the team of coating technicians by following instruction provided by the HMS Quality System and ISO 13485:2003

  1. Daily communicate with the Director on priorities, safety, quality and performance of the cleanroom.

  2. Ensure that documentation is correctly prepared for customer’s device history files.

  3. Ensuring the correct completion of documentation for customer’s device history files.

  4. Training of operators

  5. Create and/or confirm machine protocols match lot traveler

  6. Follow testing procedures indicated in lot traveler

  7. Follow validation protocols for coating process parameters and all testing parameters.

  8. Communicate with Director and/or Process Tech regarding test outcomes. Modify process parameters/chemistry specifications if requiring depending on test outcomes.

  9. Able to multitask, be proactive and have foresight of next steps required during the coating operations.

  10. Must be able to give feedback and document test outcomes, observations for customer communications.

  11. Ensure the correct labeling and packaging procedures are follow for each product

  12. Provide guidance to all direct reports and propose salary changes, dismissals and participate in hiring for cleanroom staff.

Key Performance Indicators (KPIs) to Support KRAs:

The following can done directly by the Cleanroom Lead or delegated to the Shift Leads as they become fully trained to perform these tasks.

  • Training of cleanroom shift leads in the use of work instructions and documentation used in the coating operation.

  • Actively assist coating technician(s) whenever needed in machine set-up and coating operation as well as packaging of customer product.

  • Monitor work and workmanship of coating technicians and machines through packaging and labeling completion, resolving inconsistencies or breakdowns in process.

  • Responsibly determine any issues requiring escalation to management or engineering attention

  • Assure adherence to quality standards and compliance requirements per the established QMS within the production cleanroom.

  • Promote effective communications between employees. Recommend improvements in production, staffing requirements, equipment and tooling needs and schedules, etc.

  • Inspection of customer parts and raw materials as per work instructions.

  • Inventory management of customer parts throughout the coating process within the cleanroom: customer retains, raw materials and other supplies as needed while ensuring lot separation, line clearance and traceability procedures are followed.

  • Ensures area around assigned machines are kept clean on a daily basis including personal work area, controlled environment and testing areas.

  • Successfully complete ad hoc requests and projects

  • Leads by example. Is professional, positive, consistent, impartial, and fair with all employees and shows positive enforcement of all company policies and standards.

The following Items will be guidance for all job functions that are performed at Harland Medical Systems

SAFETY

  • Follow all safety policies and procedures (both in-house and regulatory) to decrease the potential for employee injuries on the job while ensuring that direct reports are able to execute their job duties while following required safety policies and procedures.

  • Play an active role in identifying and developing new safety procedures in BU140 and throughout HMS.

  • Know the HMS emergency response plan in the event of an accident or emergency.

QUALITY

  • Follow all aspects of the HMS quality system, which are within the scope of this position.

  • Ensure that all quality procedures, processes and work instructions are followed which affects any aspects of customer products within the scope of the position

  • Be prepared and willing to train employees if required.

  • Ensure that all documentation is completed and maintained as required by customer protocols and HMS established policies and procedures

  • Play an active role in continuously improving all quality procedures, production processes and work instructions.

PERFORMANCE

  • Understand and organize work in alignment of priorities as communicated.

  • Perform work with a sense of urgency.

  • Plan / schedule work that is important but not necessarily urgent.

  • Become an expert in using all functions HMS online MRP software as required by this position.

  • Be a relentless problem solver; seeking, planning and implementing solutions to everyday problems.

  • Be ready and willing to assist other team member to complete work at peak times of production.

Qualifications:

  • 2 years’ experience in manufacturing, preferably in a controlled environment or clean room

  • Laboratory experience is a requirement or working in a production environment requiring traceability of products and documentation.

  • Written and verbal communication skills required

  • The ability to identify problems, collect and refine relevant data required to draw valid conclusions, and generate actionable analysis

  • Practical knowledge of Microsoft © Excel, Intermediate knowledge of Microsoft ©Word. General computer proficiency and ability to learn other software as needed.

If you are qualified and interested, contact:

David Coulter

Senior Director of Operations Harlan Medical Systems

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