Cleanroom Technician Team Lead

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

The Cleanroom Technician Team Lead will guide our newly established team of clean room associates. The chosen individual will not only provide leadership but will also actively participate in the hands-on assembly processes within our Class 8 cleanroom. This pivotal role is defined by its commitment to upholding the highest standards in safety, quality, delivery, and cost, all in alignment with the current Good Manufacturing Practices (cGMP).

The Cleanroom Technician Team Lead will be responsible for supervising and managing all cleanroom personnel (cleanroom technicians) and activities within the cleanroom. The Team Lead will provide continuous positive leadership and guidance to all cleanroom technicians on proper aseptic practices; cleanroom behaviours and production workflow. The Team Lead will be required to work in a fast-paced environment; work with minimal supervision; delegate tasks and be able to make quick decisions.

The candidate must possess the ability to work cross-functionally to support rapid growth and continuous improvement. This position will report directly to the Sr. Manager, Operations and will interact with many functions and levels of the business.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Team Leadership & Collaboration: Actively lead and collaborate with a team of clean room technicians, ensuring seamless operations and instilling a sense of unity and purpose.
• cGMP Adherence: Vigilantly ensure all activities are in strict adherence to the current Good Manufacturing Practices.
• Safety & Quality Assurance: Oversee and participate in the assembly process, ensuring all procedures are carried out safely and meet the company's stringent quality standards.
• Operational Excellence: Drive daily production metrics, ensuring that the team consistently meets and exceeds expectations.
• In-process Checks: Perform and oversee in-process quality assessments to ensure product quality and integrity.
• Aseptic Standards: Uphold and ensure compliance with proper aseptic techniques throughout all assembly procedures.
• Clean Room Maintenance: Supervise and partake in the daily cleaning and sanitization of the clean room, ensuring an environment free of contaminants.
• Policy Adherence: Diligently follow all documented policies and procedures, and ensure the same from all team members including work schedules, breaks and general attendance.
• Environmental Monitoring: Perform and record validation and environmental and technique microbiological monitoring
• Flexibility: Adapt to the dynamic needs of the business, assisting in Shipping and Receiving or other departments when the clean room operations are not active.

Qualifications

• H.S. Diploma or equivalent required.
• Minimum 1 years prior experience in a clean room environment preferred, preferably within the medical device sector.
• Demonstrated leadership skills with the ability to inspire and guide a team.
• Previous team lead or supervisory experience preferred.
• Comprehensive knowledge of cGMP and other relevant industry standards.
• Strong attention to detail and commitment to excellence.
• Ability to adapt to changing priorities and multitask efficiently.
• Excellent communication and interpersonal skills.
• Willingness to take on diverse roles in response to business needs.
• Must be able to lift 30 pounds regularly throughout the day
• Ability to prioritize and manage multiple tasks in a fast-paced envi