QUALITY ENGINEER

Main Tasks

Job Title:

 

 

Quality Control Engineer

 

Reports to:

 

 

Quality Manager

 

Main purpose of the job:

 

Quality Control Engineers help to ensure that manufactured products meet company and customer quality specifications; they are also responsible for designing inspection sheets and assigning inspection levels and frequencies, troubleshooting Quality issues and assisting Engineering, Production and other Departments in maintaining the Quality Systems at Schivo in compliance with ISO13485 and AS9100 requirements.

This involves working very closely with Schivo QC, Production and Engineering personnel in carrying out scheduled and random checks on product quality during the production process and also finished product tests prior to dispatch to the customer.

 

The Quality Control Engineer will also be involved with conducting investigations into non-conformances and customer complaints, performing internal audits, preparing SOP’s and templates, assisting in Validations and troubleshooting Quality issues.

 

Quality Control Engineers also play an active role in projects, as these arise, for example New Product Introduction, Quality Improvement projects, Lean Six-Sigma projects or others where Quality input is required.

 

 

Competencies

  • Detail and Process focused
  • Problem solving
  • Customer Focused
  • Ability to translate skills and knowledge to others.
  • Industry awareness

 

 

Experience and Knowledge

  • Honours Degree in Mechanical/Manufacturing/Production engineering
  • 2 Years’ experience in a production environment
  • 2 years’ experience in quality department
  • GMP experience essential
  • ISO experience desirable

 

 

 

Key duties /responsibilities:

 

 

Detail and Process focused

 

  • Design and roll out of new process/product introduction
  • New / Revised Product Documentation review.
  • Verification of 1st Article samples and associated production documentation against specification requirements.
  • Assign features to be checked by QC and associated sample sizes to ensure that product to be delivered meets customers product specification.
  • Create/update work instructions where required for Quality activities.
  • Disposition of product.
  • OOS investigations, where required for containment of product or as assigned.
  • Escalate issues to the Quality Manager where required.
  • Review and approval of DHR for Release to Stores or other internal or external customers.
  • Investigate / resolve inconsistencies in product documentation where they arise.
  • Maintain inspection and test records.
  • Review of product prior to shipment and approval of Certificates of Conformance.

 

 

Problem solving

 

  • Investigate problems as assigned.
  • Work with other departments, customers &suppliers to resolve quality issues.
  • Raise non-conformances where required.
  • Investigate and document non-conformances for area of responsibility.
  • Respond to the process owner as required.
  • Develop and Implement Corrective and Preventive Actions to reduce the risk of recurrence of the non-conformance.

 

Customer Focused

 

  • Investigate and document customer complaints for their area of responsibility.
  • Respond to the customer as required.
  • Develop and Implementing Corrective and Preventive Actions to reduce the risk of recurrence of the complaint.
  • Active participation in NPI teams to bring on-board new suppliers, components, raw materials etc.

 

Ability to translate skills and knowledge to others.

 

  • Support teamwork within the QC group and with Production & Engineering personnel.
  • Mentor and train of QC team members.

 

 

Industry awareness

 

  • Regulatory Compliance
  • Conduct Internal and Supplier Audits as required.
  • Maintain Quality Documentation in the assigned areas of responsibility e.g. Work Instructions, SOP’s flow charts.
  • Ensure that work areas and equipment are maintained in accordance with GMP standards.
  • Ensure that any maintenance and Health and Safety problems/issues are reported.
  • Maintain company Health and Safety standards including PPE (safety shoes, company uniform, safety glasses etc.).
  • Ensure compliance with company procedures at all times

 

 

Work Conditions:

 

 

  • Employee is expected to follow all safety regulations, keep work area in a clean and orderly condition, and wear appropriate Personal Protective Equipment (PPE) as required for the assigned work area(s). Working at heights will be a requirement for this position. Performs safety related duties as assigned.
  • Working conditions are normal for a manufacturing environment. Machinery operation requires the use of safety equipment to include but not limited to safety glasses and company uniform
  • Must be flexible to support company as needed

 

                       

 

** This list is not an exhaustive list of duties; you may be required to fulfil other Ad Hoc duties anywhere throughout the company as required.