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.
Qualifications
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
