Quality Engineer with Medical Devices ISO 13485
Day Shift 37.5 hours
7.30am - 4.00 Monday - Thursday 7.30am - 2.00pm Friday
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
- Oversee first production start-up of new products, including carrying out capability studies and product inspection to ensure that Customer specifications and requirements are achieved. Present findings at post first production run review meetings
- Review and sign off Packing Specifications
- 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 – essential
- Previous experience in a similar quality role – essential
- Good knowledge of quality analytical/problem solving tools and techniques gained through practical experience – essential
- Ability to handle multiple demands, to be self-managing and to work under pressure – essential.
- Ability to gain respect and credibility within the team, through demonstration of technical knowledge and transferable skills – essential.
- 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 – desired
- Experience of working within a GMP environment – desired
- Experience with ISO 13485 -Essential
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.