Senior QA & RA Administrator | Medical Devices | Gauteng

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  superseded documents and archiving of digital records;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  superseded documents and archiving of digital records;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.
  

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