Quality System Specialist I

Job Summary

Responsible for assisting in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS), while ensuring compliance to GMP requirements, FDA & ISO standards, and other regulations as they pertain to the QMS. The focus of the position is to assist in maintaining and monitoring key Quality Systems. Duties may include CAPA, Internal Audits, Supplier Audits, Affiliate Audits, External Documents, Management Review, Procedure development, key metric reporting and other key project support under the supervision of the Quality Systems Manager.

Essential Functions

The QS Specialist I will be expected to support all activities within the Quality Systems team shown below but will have primary responsibility for assisting and supporting at least one of the following:

• CAPA process – Assist with tracking, trending of approved CAPAs, and driving timely/appropriate completion of activities, ensuring root cause analysis, actions, verification of effectiveness are appropriate
• Internal Audit program – Assist with planning, conducting, reporting, and transfer of any nonconformities issued to the CAPA process and driving timely/appropriate closure of the audit
• Quality Agreements – Assist with maintaining up-to-date files, updating agreements to current template, communicating with affiliates and/or distributors regarding status under minimal supervision
• Quality Plans – Assist with issuing number, creating plan, tracking status, timely/appropriate closure
• External Documents – Assist with tracking, trending of the External Document process. Driving timely/appropriate initiation and completion of Action Plans
• Management Review – Assist with the creation and delivery of the Management Review presentation. Assist with completion and approval of the Management Review Meeting Minutes and closure of Action Items

Secondary Functions

• Attend meetings related to QS activities
• Assist with change orders/process improvements with respect to Quality Management System procedures with direction from management
• Assist with development and maintenance of a variety of metrics pertaining to Quality System activities as assigned, including data for Management Review and KPIs
• Assists and supports internal, external (including regulatory) and/or 3rd party audits, as needed
• Assists and supports duties in compliance with established business policies
• Other duties as assigned, according to the changing needs of the business

Minimum Knowledge & Experience Required for the Position

Education: Minimum of bachelor’s degree, in related scientific or technical field

Experience: Minimum 1 years (or 1 years with advanced degree) of experience in the medical device, IVD or other regulated industry

Additional Skills/Knowledge

• Previous Quality Assurance experience within a GMP regulated environment is a plus
• Good understanding of US FDA Quality System Regulations (QSR), ISO 13485:2016, Good Manufacturing Practices & Good Documentation is a plus
• Good computer skills required; expert knowledge of Microsoft Office (including Word, PowerPoint and Excel) required, experience with Enterprise Resource Planning (ERP) system (such as SAP) is a plus
• Basic understanding of change control requirements
• Basic understanding of record retention

Skills & Capabilities

• Attention to Detail: Good ability to pay close attention to detail is required
• Accuracy: Work is accurate and completeness of records
• Outstanding Performance Standards: Demonstrated good ability to meet department goals
• Ethics and Values: Integrity and Trust / Ability to be Discrete
• Delivery of Results (Action Orientation): Good ability to Learn on the Fly / Taking Initiative
• Communication: Good written and verbal communication skills
• Discretion: Acts Honest, Loyal, Trustworthy
• Multi-Tasking: Good planning, organizational and time management skills are required to support changing business needs
• Collaboration: Good ability to work with cross functional teams
• Independence: Must be self-motivated and have the ability to work under minimal supervision; must also be able to work as part of a team
• Professionalism: Must demonstrate professionalism during all interactions within company, customer and third parties
• Takes Initiative: Good ability to drive continuous improvement, correct deficiencies and to prevent recurrence
• Problem Solving: Good problem-solving skills are required

Travel Requirements: <5% of time may be required for travel