Quality Engineer in Alton - CV-Library

Quality Engineer

Alton

7.30am - 4.00pm Monday - Thursday 7.30am - 2.00pm Friday 37.5 Hours

About the role:

Reporting to the Quality Assurance Supervisor, the main purpose of this post is to ensure that any customer quality issues and consumer complaints are investigated and responded to in a timely manner. To support with investigations into non-conformities whilst ensuring that any corrective/preventative actions are effective and meet regulatory expectations, and to assist in the support of new product introduction.

The post holder will have a good knowledge of quality improvement tools and techniques and be an experienced auditor.

This is a hands-on role which will involve spending time on the production lines and some product inspection.

Key Duties and Responsibilities:

Following training, the key duties of the post are as follows

* Co-ordinate the QMS internal audit programme including planning the audits, assigning the auditors, carrying out audits, ensuring audit reports are produced and signed off in a timely manner, ensuring corrective actions are logged.

* Support the operations team in carrying out investigations into internal non-conformities or quality issues -advise problem solving techniques that could be used to establish the root cause of the issue and identify appropriate corrective and/or preventative actions where applicable and in a timely manner.

* Manage the Change Control Process

* Investigate customer quality issues and consumer complaints and ensure that responses are provided in a timely manner.

* Review and complete Deviations in a timely manner- allocate actions to the QC department as applicable

* Attend customer meetings as required

* Monitor the corrective and preventative action (CAPA) process by ensuring proposed actions are relevant and applicable and by carrying out verifications on these actions.

* Carry out effectiveness checks on CAPAs.

* Assist in the review and update of Risk Assessments as required

* Support the new product introduction process by providing specific quality engineering expertise to NPI projects

* Participate in line trials. Present findings at post line trial run review meetings

* Assist and support the Administration Team with completion of PQR reports

* Carry out any other reasonable projects and duties as determined by the Quality Assurance Supervisor or Quality Manager

Formal Qualifications and Experience required:

* Qualified and experienced internal auditor

* Previous experience in a similar quality role

* Good knowledge of quality analytical/problem solving tools and techniques gained through practical experience

* Ability to handle multiple demands, to be self-managing and to work under pressure

* Ability to gain respect and credibility within the team, through demonstration of technical knowledge and transferable skills

* Ability to manage a team, provide support and develop team members in line with Company values.

* Educated to degree level or equivalent in a science, engineering or manufacturing related discipline

* Experience of working within a GMP environment

Person Specification:

* A confident people person able to influence and communicate effectively with all levels of the company

* Strong verbal communication and interpersonal skills. Ability to listen, discuss and advise

* A team player

* Ability to make own decisions

* Ability to handle multiple demands and changes in priority and workload

* Ability to gain respect and credibility through demonstration of technical knowledge and transferable skills

* Advanced level of literacy and numeracy required

* Ability to use computerised information systems to input, retrieve and update all relevant data - Candidates should be able to demonstrate that they are comfortable with computer systems. It is not considered relevant where that experience has been gained.

* Good knowledge of Microsoft Office package - Word, Excel, Outlook and PowerPoint - A moderate understanding is essential