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Regulatory Affairs/Quality Assurance (RAQA) Specialist

Company: TeDan Surgical Innovations
Location: Sugar Land
Posted on: May 5, 2022

Job Description:

Company Description:

TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.

Duties/Essential Job Functions:
Independent self-starter who is capable of planning schedules, control plans and leading projects as assigned
Act as core team member of RA/QA for project development life cycle
Maintain State License renewals and annual registrations
Responsible for creating Clinical Evaluation Reports as needed
Review and approve marketing/training materials
Support new and on-going manufacturing efforts including final inspection, test of components and assemblies, and disposition of discrepant materials
Release ECO documents per procedure
Assist with resolution of product and process defects as determined through failure analysis, focusing on root cause analysis and implementation of effective corrective action
Awareness of General TSI Quality Management System (QMS), Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and Complaint Handling through annual TSI Training.
Other responsibilities assigned by supervisor and including vendor site audits, attending surgeries and general corporate functions associated with role as RA/QA Specialist I, II, III professional

Work experience in a regulatory affairs/quality assurance position within the Medical Device industry
Specialist II: 5-10 years, depending on scope of responsibility
Specialist III: 5-15 years, depending on scope of responsibility
Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred
Good knowledge of product development and processes in Medical Device industry
Experience with regulatory audits and inspections
Microsoft Word and Excel proficiency
Technical report writing skills
Data interpretation and basic statistical analysis
Demonstrated attention to detail
Ability to work independently or in a team environment
Excellent written and verbal communication
Strong organizational and analytical skills
Independent organization and prioritization of multiple tasks
Communication: Ability to internally and externally discuss and clearly define key issues and independently develop course of action/plans
Strong technical writing skills and ability to create SOPs
Interpersonal: Ability to cooperate and support team members and ability to coordinate interdepartmental activities and to resolve individual conflicts and issues
Business Acumen: Require a basic understanding of business and financial impact of project
Teamwork: Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Abide by team decisions

Required Education/Licensing/Certification:
Specialist II, III: College degree in sciences and/or relevant work experience

Physical Requirements:
Business casual attire.
Occasionally requires attending corporate functions
Occasionally may require travel (5-10%).

Keywords: TeDan Surgical Innovations, Sugar Land , Regulatory Affairs/Quality Assurance (RAQA) Specialist, Other , Sugar Land, Texas

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