Quality Specialist

Position Summary

The Quality Specialist supports the effective implementation and maintenance of quality systems under the direction of the Quality Systems Manager. This role is responsible for ensuring the control, security, integrity, and availability of quality documentation while also contributing to key quality system functions such as metric reporting, document control, and audit participation. A strong background in quality assurance within the medical device industry, along with excellent organizational and communication skills, is essential.

Principal Responsibilities

The key areas of responsibilities are:

•Support site goals and objectives as directed by leadership
•Support change control within Global and Legacy Agile systems
•Promote compliance through effective change management, document retention policies, Good Documentation Practices and archiving / scanning Device History Records
•Analyze and review quality system documents to ensure accuracy, completeness, and compliance.
•Participate in internal and external audits, providing support and documentation as needed.
•Execute internal audits, write reports and ensure timely follow-up on corrective actions.
•Work collaboratively with cross-functional teams to ensure timely execution of corrective and preventive actions (CAPA) phases
•Assist in the development, implementation, and maintenance of the quality management system (QMS) in compliance with regulatory requirements (e.g., FDA, ISO 13485).
•Backup support for the training associate.
•Collect, analyze and report quality metrics to drive continuous improvement
•Ensure compliance with regulations, laws and guidelines
•Perform additional duties as assigned
This position requires direct contact with an implantable device. ☐ Yes ☒ No

Education / Experience Requirements

•Minimum of 2-3 years’ experience in Quality Assurance experience required.
•Experience in a manufacturing environment, with preference in a regulated or medical industry.
•Critical thinker with a demonstrated exposure to compliance requirements.
•Strong computer skills including Microsoft Office
•Key competencies in verbal and written communication; attention to detail

Specialized Skills / Other Requirements

•Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
•Working knowledge and/or experience with SAP, Veeva Vault and AGILE strongly preferred.
•Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•Good listening, verbal, and written communication skills
•Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•Ability to prioritize and adapt to shifting priorities.
•Ability to work independently with limited supervision.

TRAVEL REQUIRED: As needed to support customers < 5%

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