Quality Systems Specialist

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.

Job Description

POSITION SUMMARY:

The Quality Systems Specialist (QSS) is responsible for supporting Quality Systems requirements in maintaining a compliant Quality System (ISO, FDA 21 CFR 820, etc.). Specifically, this role is responsible for change control activities, including dissemination of training, obtaining required approvals and organized filing of released records.

PRIMARY DUTIES & RESPONSIBILITIES:

• Responsible for processing quality system, marketing collateral, and product documenting engineering change orders, reviewing for completeness and releasing controlled copies for use.

• Reviews quality system documents and records for completeness, scans, organizes, and files electronically and physically

• Administer, manage templates, and distribute documents for signature within DocuSign platform

• Administer and maintain quality system training (new hire, ongoing, annual, etc.) activities in eLMS (Absorb)

• Support CAPA action implementation and verification activities.

• Reviews quality system documents and records for completeness, scans, organizes, and files electronically and physically

• Supports quality system audits (FDA, ISO, internal, etc.)

• Other duties as assigned

Qualifications

KNOWLEDGE, SKILLS, AND ABILITIES:

• Must be able to independently use Adobe and MS Office computer software including Word, Excel, PowerPoint

• Must demonstrate the ability to work in a fast-paced work environment

• Must demonstrate a strong sense of ownership and accountability

• Must demonstrate strong interpersonal and verbal/written communication skills

• Must be extremely detail oriented and able to demonstrate strong organizational and communication skills

• Ability to exercise good judgment, problem solving and decision-making abilities

• Less than 10% of travel required in this role

EDUCATION & EXPERIENCE:

• Minimum high school diploma or equivalent is required.
• A minimum of 2 years' experience in medical device or pharma quality systems role (e.g. Document Control, Quality Control, Post Market, etc.) is required

Additional Information

WORK ENVIRONMENT:

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.

This job description is not a contract and does not affect the at-will nature of your employment relationship with Treace Medical Concepts, Inc., Furthermore, this job description is not intended to be all-inclusive and does not and cannot address every responsibility or duty you may be expected to perform during your employment. Treace Medical Concepts, Inc., reserves the right to modify or amend this job description at its discretion, without prior notice.

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

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.

Treace is a drug free employer.