Quality Engineer
4 weeks ago
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
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