Cleanroom Technician

Company DescriptionTreace'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

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 interact with many functions and levels of the business.

PRIMARY DUTIES AND RESPONSIBILITIES

Engage in various cleanroom operations, ensuring all activities align with our established standards and cGMP protocols.

Adhere to safety protocols and contribute to the continuous enhancement of product quality through meticulous attention to detail.

Oversee the setup, calibration, and maintenance of cleanroom equipment, ensuring optimal functionality at all times.

Maintain the integrity of the cleanroom environment by consistently following aseptic techniques in all processes.

Assist in regular cleaning and sanitization schedules, ensuring the environment remains contaminant-free.

Accurately log all activities, ensuring traceability, and contribute to process documentation when necessary.

Work in tandem with the Clean Room Team Lead and other cleanroom associates, ensuring seamless operations and effective communication.

Diligently follow all documented policies and procedures including the company's Compliance Program, FDA regulations and guidance, work schedules, breaks, and general attendance policies.

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

EDUCATION AND EXPERIENCE

H.S. Diploma or equivalent required.

Minimum of 1+ years' operations experience (shipping, receiving, assembly, manufacturing) required.1+ years prior experience in a clean room environment strongly preferred, preferably within the medical device sector.

Additional InformationAll your information will be kept confidential according to EEO guidelines.

Treace's Privacy PolicyIt 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.