Job Description

** POSITION SUMMARY**

We're seeking a detail-oriented Cleanroom Technician to join our dedicated team, working within our state-of-the-art Class 8 cleanroom. The successful candidate will be integral in ensuring that all operations within the cleanroom adhere to our rigorous standards, as defined by current Good Manufacturing Practices (cGMP). This role demands precision, a strong commitment to quality, and a keen understanding of the vital processes and procedures associated with cleanroom environments. A passion for patient safety and value are critical for success.

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:**

• Operational Excellence : Engage in various cleanroom operations, ensuring all activities align with our established standards and cGMP protocols.
• Safety & Quality Assurance: Adhere to safety protocols and contribute to the continuous enhancement of product quality through meticulous attention to detail.
• Equipment Maintenance : Oversee the setup, calibration, and maintenance of cleanroom equipment, ensuring optimal functionality at all times.
• Aseptic Procedures : Maintain the integrity of the cleanroom environment by consistently following aseptic techniques in all processes.
• Cleanroom Sanitization : Assist in regular cleaning and sanitization schedules, ensuring the environment remains contaminant-free.
• Documentation : Accurately log all activities, ensuring traceability, and contribute to process documentation when necessary.
• Team Collaboration: Work in tandem with the Clean Room Team Lead and other cleanroom associates, ensuring seamless operations and effective communication.
• Policy Adherence: Diligently follow all documented policies and procedures including work schedules, breaks, and general attendance.

Qualifications

** Job Qualifications and Key Competencies:**

• H.S. Diploma or equivalent required.
• 1+ years prior experience in a clean room environment preferred, preferably within the medical device sector.
• Comprehensive knowledge of cGMP and other relevant industry standards.
• Must be able to lift 30 pounds regularly throughout the day
• Ability to prioritize and manage multiple tasks in a fast-paced environment.
• Able to stand for extended periods throughout the day

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Compliance:

Every Treace Medical employee is responsible for adhering to the AdvaMed Code of Ethics on Interactions with Health Care Professionals and any related ethical, compliant business practices, including, but not limited to, compliance with the Company's Compliance Program, FDA regulations and guidance, Anti-Kickback Statute, and other Federal, state and/or local laws. Every employee is responsible to complete required compliance training successfully and on­ time.

Treace Medical Concepts, Inc. is a drug-free workplace. All employment is contingent upon successful completion of a drug and background screening.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer

Treace is a drug free employer.