Senior Quality Assurance Specialist - Cook Group

Overview

The primary function of the Senior Quality Assurance Specialist is to ensure that entities are always inspection ready.  This includes providing the support and leadership needed to investigate and resolve quality-related issues.  This role may lead both internal and external audits, while also acting as a subject matter expert in related key processes.  The Senior Quality Assurance Specialist should be a champion in supporting the quality culture within the organization.

Responsibilities

• Author and perform investigations related to Quality Issues including nonconformances/deviations (including full root cause analysis, rework inspections where applicable).
• Coordinate /investigate / own CAPAs / SCARs within various electronic systems.
• Lead change management activities (which may include attending Quality Review Board Meetings, and reviewing changes for impact to established QMS).
• Lead the execution of both process and document control – I don’t understand this point either
• Perform Risk Assessment and FMEA Activities.
• Support hiring process as required and act as mentor for new hires
• Author documentation e.g. procedures, policies, instructions, training, and nonconformances.
• Own Quality Management Review data collection and analysis (including: preparation of Key Process Attachments, meetings minutes and action items.
• Prepare quality related reports as required by the organization.
• Conduct, schedule and support both Internal and External Audits as required.
• Lead relevant Continuous Improvement activities
• Serve as a delegate for the Senior Manager, Quality Assurance.
• Author and perform trending of quality data, ensuring proper application of CAPA and feedback loops are effective.
• Lead documentation gap analysis activity as required in relation to relevant standards / Regulations / legislation.
• Lead regulatory importer/Distributor obligations as per applicable market requirements
• Other duties as assigned by management.
• Ensure compliance with Cook Medical’s Code of Conduct, Company Values, Competencies, and Ethics and Compliance requirements.

Qualifications

• Bachelor's degree in related field, or experience of such kind and amount to provide a comparable background; min 5 years related experience.
• Knowledge of medical device regulations, including pertinent standards / regulations. 
• Proficiency in Microsoft Office Software (Word, Excel, PowerPoint, and Outlook)
• Demonstrable communication skills with proven ability to work in a collaborative and independent manner throughout various levels of the global organization with minimal supervision
• Proven ability to lead both local and global projects.
• Ability to remain calm and receptive in fast-paced situations.