CR-Quality Specialist at Theragenics Corp

Alajuela, Alajuela Province, Costa Rica -

Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Regulatory Compliance, Inspection Techniques, Documentation Skills, Root Cause Analysis, Corrective Actions, ISO 13485, FDA Regulations, Validation Activities, Collaboration, Internal Audits, Quality Metrics, Statistical Process Control, Nonconformance Management, Risk Management, Visual Inspection Systems

Industry

Medical Device

Description

Job Description The Quality Control Specialist is responsible for ensuring that products meet established quality standards and regulatory requirements. This role involves inspecting materials and finished goods, reviewing documentation, supporting investigations, and collaborating with cross-functional teams to maintain and improve quality processes. Key Responsibilities: · Perform inspections and tests on incoming materials, in-process components, and finished products according to defined specifications and sampling plans. · Document inspection results and maintain accurate quality records. · Identify nonconformities and support root cause analysis and corrective actions. · Ensure compliance with internal procedures, ISO 13485, FDA, and other applicable regulations. · Support validation activities, including equipment qualification and process validation. · Assist in the development and revision of quality procedures, work instructions, and visual aids. · Collaborate with production, engineering, and supply chain to resolve quality issues. · Participate in internal audits and support external audits as needed. · Monitor and report quality metrics and trends. · Prepare, route, and release documentation per approval processes. · Create and present summary reports for key stakeholders. Qualifications: · Technical degree or equivalent experience in quality, engineering, or related field. · Minimum 5 years of experience in quality control or quality assurance, preferably in a regulated industry. · Knowledge of inspection techniques, sampling plans (e.g., AQL), and measurement tools. · Familiarity with ISO 13485, GMP, and regulatory standards. · Strong attention to detail and documentation skills. · Ability to work independently and in a team environment. Preferred Skills: · Experience with nonconformance management (NCMRs), ECNs, and CAPA processes. · Understanding of statistical process control (SPC) and risk management. · Experience with visual inspection systems or automated inspection tools.

Responsibilities

The Quality Control Specialist is responsible for ensuring that products meet established quality standards and regulatory requirements. This role involves inspecting materials and finished goods, reviewing documentation, supporting investigations, and collaborating with cross-functional teams to maintain and improve quality processes.