Senior QA & RA Administrator | Medical Devices | Gauteng

Salesworx Recruitment (Pty) Ltd; Johannesburg; On-site; ZAR 500,000 - 800,000; Full time

Job summary

A leading Medtech company is looking for a Senior QA & RA Administrator in Midrand, responsible for managing document control, nonconformance assessment, and quality management systems. The ideal candidate will have significant experience in the medical devices industry, advanced computer skills, and a degree in a relevant field.

Benefits

50% medical aid

50% provident fund

Qualifications

• Minimum Matric/Gr12 required.
• 2-5 Years working experience in the Medical Industry is essential.
• Experience with Quality Management Systems ISO 13485 is non-negotiable.

Responsibilities

• Managing document control and ensuring compliance with ISO requirements.
• Conducting internal audits and managing nonconformance assessments.
• Overseeing customer complaint management and risk management processes.

Skills

Advanced Computer Skills

Attention to Detail

Interpersonal Skills

Problem Solving

Fluency in English

Education

Degree: Science/ Medical/ Biological/ Technical

Job description

Our client is a leader in the field of Medtech devices and wishes to employ a Senior QA & RA Administrator. Experience in the medical devices industry is non negotiable.

Based in Midrand, you will report to the Group QA & RA Manager.

AREAS OF RESPONSIBILITY

DOCUMENT CONTROL

• Managing the Group Document Control programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Manage document email address and Share-Point;
  
• Maintain Document Index for internal documents;
  
• eQMS Document Controller Function review and promote documents for approval after review;
  
• Support teams with generation, formatting and content creation of SOP’s;
  
• Issue approved documents for training and follow up to completion as per training matrix create implementation pack for document to be rendered effective;
  
• Effective documents to be distributed within the organisation as digital and hard copies;
  
• Retrieval of superseded documents and archiving of digital records;
  
• Trend KPI data and provide report timeously for Management Review
  
  

EXTERNAL DOCUMENT CONTROL

• Maintain Document Index for External and external documents;
  
• Control the issue of external documents;
  
• Review internal and external documents and perform GAP assessment, raise change controls and update documents to align with external document requirements;
  
• Retrieval of superseded documents and archiving of digital records;
  
• Trend KPI data and provide report timeously for Management Review.
  
  

NONCONFORMANCE/ DEVIATION MANAGEMENT

• Managing the Group and individual site Nonconformance/ Deviation databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Support departments with investigations and determining root causes of nonconformities and ensure CAPAs process initiated where required;
  
• Trend KPI data and provide report timeously for Management Review.
  
  

NON-CONFORMING PRODUCT

• Maintain Index for Non-conforming products;
  
• Review and retain disposition files;
  
• Trend KPI data and provide report timeously for Management Review.
  

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CAPA

• Managing the Group and individual site Corrective and Preventative Action programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Support departments with investigations and determining root causes of nonconformities;
  
• Trend KPI data and provide report timeously for Management Review.
  

INTERNAL & EXTERNAL AUDITS

• Perform allocated internal audits as assigned;
  
• Managing the Group and individual site Internal Audit databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Support departments with investigations and determining root causes of nonconformities and ensure CAPAs process initiated where required;
  
• Trend KPI data and provide report timeously for Management Review;
  
• Support with External Audits as per allocated actions.
  
  

SUPPLIER QUALITY

SUPPLIER QUALITY

• Managing the Group and individual site Supplier Quality programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for monitoring and evaluations;
  
• Perform assigned Supplier Audits;
  
• Review and evaluation of the Approved Supplier List and suppliers as well as raising and communicating supplier non-conformances (Supplier Quality Liaison);
  
• Initiate Change Controls for supplier change notifications received and follow up on actions ensuring completion per timelines;
  
• Trend KPI data and provide report timeously for Management Review
  

CHANGE CONTROL MANAGEMENT

• Managing the Group Change Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Schedule change meetings and ensure change initiation documents are available;
  
• Maintain Change Control Index and follow up on action completion;
  
• Collate change control action evidence and once all evidence available prepare change pack for implementation and approval;
  
• Trend KPI data and provide report timeously for Management Review
  
  

CUSTOMER COMPLAINT MANAGEMENT

• Managing the Group Customer Complaint Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Customer complaint receipt, coordination and maintaining databases and ensure that deadlines are met by the Group in resolving and providing information to the suppliers for product complaints;
  
• Assist and support departments with internal complaint investigations, root cause identification and CAPA determination;
  
• Notify Product Manager, Sales Manager and Sales Rep promptly on receipt of investigation results for reporting to customer;
  
• Trend KPI data and provide report timeously for Management Review.
  

RISK

• Set Up Process and Risk Files and continuous maintenance and improvement of the system;
  
• Analysis of risk and implementation of corrective actions for Quality Management Systems. Support Teams with Product Risk Assessments in accordance with Group policies and procedures, ISO 13485 and statutory and regulatory requirements;
  
• Managing the Group Risk Management programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed;
  
• Trend KPI data and provide report timeously for Management Review.
  

VALIDATION

• Managing and Maintaining Validation Schedules;
  
• Generate validation protocols and reports and support departments where applicable;
  
• Support in validation activities for areas under responsibility;
  
• Follow up with teams until completion of activities;
  
• Trend KPI data and provide report timeously for Management Review.
  
  

KPI DATA COLLECTION AND ANALYTICS

• Follow up with all sites and departments on monthly KPI data metrics;
  
• Ensure data is provided as per approved KPI Metrics;
  
• Perform data analysis and trending remarks.
  

CALIBRATION MANAGEMENT

• Managing the Group Calibration programs and databases in alignment with ISO 13485 requirements and ensure deadlines are not missed for Calibration;
  
• Maintain and update Calibration Index and update Shared-Point with calibration certificates for the group;
  
• Trend KPI data and provide report timeously for Management Review.
  

GENERAL

• Support with External Audits as per allocated actions:
  
• Document Control
  
• Reviewing and updating of Standard Operating Procedures and Quality Documents;
  
• General administrative duties including archiving, filing, issue of Quality Documents
  
• Training
  
• Ensure assigned training is completed timeously.;
  
• Provide training on areas under responsibility.
  
• Continuous Improvement
  
• Individual Quality Improvement Projects are assigned on an annual basis are completed in a timeous manner;
  
• Identify improvement areas in processes under responsibility.
  

RAD CON, NRCS, ICASA LICENCE APPLICATIONS

• Support in processes where actions are assigned.
  

ASSISTANCE WITH SAHPRA APPLICATIONS

• Support in processes where actions are assigned.
  
  
  
  
  

Requirements

Qualifications

• Matric/ Gr12 is a minimum requirement;
  
• Degree: Science/ Medical / Biological/ Technical (Preferred)
  
  

Experience required

• Advanced Computer Skills (MS Office – Word, Excel, Powerpoint, Teams) - Non-Negotiable;
  
• 2-5 Years working experience in the Medical Industry – Non-Negotiable;
  
• Experience with data collection and trending;
  
• Experience with Quality Management Systems ISO 13485 or ISO 9001 or any other ISO standard – Non-Negotiable;
  
• Experience with Regulatory Affairs and understanding of regulations – Preferred.
  
  

• Highly organized, with attention to detail, producing and expecting highly accurate work within allocated timelines;
  
• Methodical and logical structure of executing activities;
  
• Excellent interpersonal skills;
  
• Ability to develop, lead, and maintain an effective action completion;
  
• Fluent in English, verbal and written;
  
• Ability to operate & communicate at all levels – verbally & in writing;
  
• Able to follow and issue verbal and written instructions;
  
• Flexible, conscientious approach;
  
• Logical approach to good problem solving and solution driven;
  
• Energetic and able to work independently;
  
• Follow up skills and ability to be assertive in meeting deadlines.
  
• Willingness to learn and someone who has a hunger to grow and make a difference
  
  
  

Benefits

50% medical aid
50% provident fund