Director of Quality Assurance & Regulatory Affairs

Director of Quality Assurance & Regulatory Affairs

The Director serves as the head of the Quality Management and Regulatory Affairs team and leads, manages, and supports all medical device Quality System and regulatory activities. Serves as Management Representative and Person Responsible for Regulatory Compliance (PRRC).

• 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.
• Ensure compliance with DemeTECH Quality Policies, cGMP, ISO, and MDD/MDR quality system requirements.
• Review and approve all quality system documentation,тация: SOPs, WIs, Forms, Validation Protocols and Reports, Device Master Records
• Review and approve all Qualification and Validation Protocols and Reports.
• Coordinate ISO certification and maintenance.
• Guide the management team to ensure operations are within required regulatory guidelines for products from final acceptance and compliance perspective.
• Maintain quality system performance metrics.
• Ensure conformity of the device to the manufacturer’s QMS prior to release; keep technical documentation and EU Declaration of Conformity (DoC) current.
• Ensure effective transfers of new products into production that meet all quality requirements for the classification.
• Conduct the Managementφοίτητα Review and provide reports of quality metrics tracking to top management.
• Authorize rework of non-conforming products and conduct material review and disposition at rework completion. Evaluate product specifications before final release.
• Oversee the environmental monitoring program; evaluate returned product and dispositions.
• Notify management of any product quality issues and major deviations.
• Conduct product recalls and/or vigilance reporting.
• Oversee and perform internal audits and audits of external suppliers and service providers.
• Host external auditors, customers, and regulatory inspections, including FDA and foreign agencies.
• Oversee and maintain the Supplier Qualification Program.

• BS in Chemistry, Biology, Biomedical Engineering, or a similar scientific/technical field.
• Working knowledge of cGMP, ISO 13485, and EU Medical Device Directive (MDD)/Regulations (MDR).
• Fluentauga in English;
  Spanish is a plus.

Excellent verbal and written communication skills; involves contacts with individuals inside and/or outside the organization with a consistent pattern of information provided.

• Organizational skills
• Excel
• Minitab
• Presentation skills
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Zero+

Collect, interpret, and analyze complex data. Demonstrated proficiency in supervising and motivating subordinates, handling multiple projects, and meeting deadlines.

Minimum of 5‑10 years of regulatory/quality assurance or quality engineering supervisory experience in an FDA‑registered facility for medical device manufacturing. Requires thorough knowledgeodels; knowledge of medical device regulations and their appropriate application to ensure compliance.

Director

Full‑time

Quality Assurance

Medical Equipment Manufacturing