DemeTECH Corporation · 2 weeks ago
Director of Quality Assurance & Regulatory Affairs
Miami, FL
Full-time
Onsite
Lead/Staff, Director/Executive
5+ years expDemeTECH Corporation is seeking a Director of Quality Assurance & Regulatory Affairs to lead and manage the Quality Management and Regulatory Affairs team. This role involves overseeing all medical device Quality System and Regulatory activities and ensuring compliance with relevant quality policies and regulations.
Health CareManufacturingMedicalMedical Device
Hiring Manager
Karla Arguello
Responsibilities
Manage the site Quality Management System, including management reviews, complaint handling, CAPA system, document control, change control, calibration, validation maintenance, internal auditing, training, and manufacturing support
Ensures compliance with DemeTECH Quality Policies, cGMP, ISO, MDD/MDR quality systems requirements
Review and approve all quality system documentation, including but not limited to: Standard Operating Procedures (SOPs), Work Instructions (WIs), Forms, Validation Protocols and Reports, Device Master Records, Product Labeling, and Specifications
Review and approve all Qualification and Validation Protocols and Reports
Coordinate ISO certification and maintenance
Guiding the management team to ensure that operations are within the required regulatory guidelines for products from a final product acceptance and compliance perspective
Maintain quality system performance metrics
Ensure conformity of the device to the manufacturer's QMS prior to release
Ensure technical documentation and EU Declaration of Conformity (DoC) are current
Ensure effective transfers of new products into production that meet all Quality requirements for the classification
Conduct the Management Review, providing reports of tracking of Quality Metrics to Top Management
Authorize the rework of non-conforming product and conducts the material review and disposition at the completion of the rework
Evaluates whether or not product does or does not meet all specifications and requirements prior to final release
Oversee the environmental monitoring program
Evaluate returned product and dispositions product
Notify Management of any Product Quality issues and major deviations
Conducts product recalls and/or vigilance reporting
Oversee/perform internal audits and audits of external suppliers and service providers
Host external auditors, customers and regulatory inspections including FDA and foreign regulatory agencies
Oversee and maintain Supplier Qualification Program
Manage communication with all economic operators
Qualification
Required
Education: BS Chemistry, Biology, Biomedical Engineering, or similar scientific/technical field
Working knowledge of cGMP, ISO 13485, and EU Medical Device Directive (MDD)/Regulations (MDR)
Fluent in English
Excellent verbal and written communication skills
Organizational Skills
Excel
Minitab
Presentation Skills
Project Management
Results Driven
Mathematical Skills
Technical Capacity
Thoroughness
Time Management
Collect, interpret, and/or analyze complex data and information
Demonstrated proficiency in supervising and motivating subordinates
Proven ability to handle multiple projects and meet deadlines
Minimum of 5-10 years regulatory/quality assurance or quality engineering supervisory experience in an FDA registered facility for medical device manufacturing
Requires thorough knowledge of FDA Quality System Regulation (QSR) experience for medical device manufacturing
Knowledge of the Medical Device regulations and their appropriate application is needed to assure compliance with regards to manufacturing
Preferred
Spanish is a plus
Company
DemeTECH Corporation
DemeTech Corporation is a world-renowned leader in surgical sutures and blades.
51-200 employees
H1B Sponsorship
DemeTECH Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (2)
Funding
Current Stage
Growth StageLeadership Team
Benjamin Carrillo
CFO/Controller
Christopher Arguello
Chief Operations Officer
Company data provided by crunchbase