Quality Systems Specialist
4 weeks ago
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.)
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
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.
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