Sr. 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 Sr. Quality Systems Specialist (SQSS) is responsible for executing and supporting Quality System requirements in maintaining a compliant Quality System (ISO, FDA 21 CFR 820, etc.).  Specifically, this role is responsible for creating procedures, assessing changes to procedures, auditing for compliance to procedures, leading CAPA system activities and recall activities, where required.

PRIMARY DUTIES & RESPONSIBILITIES:

• Create and update quality system procedures, including performing biennial reviews to drive continuous improvement, align best practices, procedures and applicable regulations (FDA, ISO, etc.)
• Responsible for assessing impacts resulting from proposed changes to quality system procedures
• Administer, provide training and maintain SolidWorks Product Data Management (PDM) system
• Administer, manage templates, and issue envelopes for signature within DocuSign platform
• Administer and maintain quality system training (new hire, ongoing, annual, etc.) activities in eLMS (Absorb)
• Supports standards review process by continuously monitoring regulations and guidance documents for required updates
• Responsible for processing quality system, marketing collateral, and product documenting engineering change orders, reviewing for completeness and releasing controlled copies for use.
• Performs internal quality system audits (for areas independent of responsibilities)
• Supports quality system documents and records for completeness, scans, organizes, and files electronically and physically
• Support post market surveillance activities, as needed
• Executes health hazard evaluations and field action activities with direction from the Recall Coordinator.  Identify scope of product holds, perform traceability, and physical quarantine of impacted products.
• Investigate potential non-conformances and recommend CAPA activity to manager.  Support CAPA investigations for root cause determination and action implementation/verification.
• Distribute documents for approval and obtain signatures from team members (DocuSign)
• Participates in 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 required.  An associate or bachelor’s degree in life sciences is strongly preferred.
• A minimum of 5 years’ experience in medical device or pharma quality systems role (e.g. Document Control, Quality Control, Post Market, etc.) is required
• Prior root cause analysis training is preferred
• Quality system auditor training or certification is preferred (ISO, other)

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 y