The Senior Quality Assurance Specialist maintains quality management systems, resolves quality issues, leads audits, and mentors new hires while ensuring compliance with regulations.
Overview
The primary function of the Senior Quality Assurance Specialist is to ensure that entities are always inspection ready while being a champion in supporting the quality culture within the organization. The primary function will be to maintain the entity's quality management system while investigating and resolving quality related issues.
Please note that this position is a 12 month contract.
Find out more about Cook Medical here
Responsibilities- Responsibilities
- Author and perform investigations related to Quality Issues including nonconformances/deviations (including proper 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.
- 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.
- Author and perform trending of quality data, ensuring proper application of CAPA and feedback loops are effective.
- Perform gap analysis (documentation/against relevant standards)
- Other duties as assigned by management.
- Bachelor's degree in related field, or experience of such kind and amount to provide a comparable background; preferred 5 years related experience.
- Knowledge of medical device regulations, including pertinent standards is preferred
- Proficiency in Microsoft Office Software (Word, Excel, PowerPoint, and Outlook)
- Must have effective communication skills with proven ability to work in collaborative and independent work situations and environments with minimal supervision
- Proven ability to lead both local and global projects.
- Ability to remain calm and receptive in fast-paced situations.
- Ability to adhere to safety requirements
- Ability to comply with the Cook Code of Conduct, Company Values, Competencies, and Company Compliance requirements
- Physical Requirements
- Works under general office environmental conditions
- Sitting for extended periods utilizing close visual acuity for working with computers, etc.
- Must be able to perform the essential functions of the job. (Subject to reasonable accommodation requirements under the ADA-AMER)
- Ability to travel between Cook facilities as required
- Regional Requirement
- Understand ISO 13485 and other regulatory requirements within a distribution and import environment
- Coordinate/Conduct//Lead training of staff to QMS
- Support Regulatory Affairs in working with government authorities in regard to quality issues as needed
- Prepare and Execute Quality Plans
- Ability to meet required deadlines for projects/tasks
- Perform gap analysis (documentation/against relevant standards
- Understand and be able to apply principles of good practices pertaining to warehousing and distribution
- Perform Quality reviews on product holds/releases within the required system
Top Skills
MS Office
Quality Management Systems
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