Quality System Engineer - Abingdon-On-Thames Jobs

Job Description

Job title

Quality Systems Engineer

Job type

Permanent

Primary function

• Support QARA Management, the QARA team and the Operations Teams in driving manufacturing excellence and cultural change/improvement.
• To make quality decisions on product & quality management systems and to advise on and assist with hands-on practical operation changes and improvements.
• To monitor and ensure compliance with international Quality and regulatory standards ISO 13485, US FDA, UK MDR, EU MDR & Brazil and other regulatory requirements where Penlon’s devices are placed.
• Ensuring quality requirements and manufacturing/production requirements are considered without detriment to either.
• Ensure that all processes needed for the Quality Management System (QMS) are established, implemented and maintained.
• Input and support continuous improvement within Penlon’s QMS processes and procedures.
  Identify and implement continuous process improvement projects, methodologies and tools to effect efficiency change and associated cost reductions / Lean.
• Measure progress and report monthly against quality objectives.
• Help define quality procedures in conjunction with all functions.  Bring together staff of different disciplines and drive the group to plan, formulate and agree comprehensive quality procedures.  Work with department managers to assist them in the creation and maintenance of their procedures and ensure that documents and tests are planned, formulated and agreed.
• As Voice of the Customer, ensure the promotion of awareness of customer requirements throughout the organization in adherence with the Quality Policy.
• Perform other tasks as requested by QARA Management.

Responsibilities under QARA RACI (Responsible, Accountable, Consulted, Informed)

Control of non-conforming process: (R) Responsible

• Manage through to completion the Concession & CAPA process in a timely manner.
• Coordinate Concession and CAPA documents and track status of corrective action to ensure Deviation and CAPA documents are complete, and all corrective actions are closed.
• Raise non-conformities as required.
• Create and distribute status reports to Engineering and Management staff.

Document Control: (R) Responsible

• Management & coordination of the documentation control process.
• Responsible for review and approval of documents and procedures in compliance with companies accredited quality management systems.
• Support the maintenance of the documentation / repository in order to meet the applicable quality system and regulatory requirements.
• Help define quality procedures in conjunction with all functions.  Bring together staff of different disciplines and drive the group to plan, formulate and agree comprehensive quality procedures.  Work cross-functionally to assist them in the creation and maintenance of their procedures.

Internal Audit Process: (R*) Responsible in part

• Participate as an auditor in the internal audit process of Penlon’s quality system.
• Support the coordination of the audit schedule, plan and database.
• Follow-up on internal audit reports and corrective actions.
• Support the training of new internal auditors.
• Submit status reports to management when requested.
• Review audit reports prior to submission for final approval.

Complaints: (R) Responsible

• Input, co-ordinate and monitoring on a regular basis to aid in the timely progression and closure of complaints.
• Support investigations and corrective/preventive actions associated with complaints.
• Working with other departments providing information for risk evaluations and reportable events.
• Generate and communicate metrics with summary reports as improvement inputs to the organisation.

Product development and change control: (R*) Responsible in part

• Provide quality assurance requirements input to the design and change control process.
• Work with Production Engineering to ensure supporting evidence, validations and associated risk has been considered with all change requests.
• Assist the product development team by providing quality assurance requirements input to the development and transfer to production for new devices and their manufacturing technologies. Progress and manage improvements to the quality system and preventive actions driven from internal and external knowledge.
• Sample Approvals; to work with Production Engineering and Production to ensure that all compliance requirements have been met with form, fit, function & supplier status of sample approvals.
• To be a key approval signatory for Engineering Changes, Validations and Sample Approvals on behalf of Quality Assurance.

Process Quality Control: (R*) Responsible in part

• Support with input for ERP system for Incoming Inspection.
• When necessary, provide quality alerts to production as correction aids.
• Work with production and production engineering on process quality issues to bring to solution; support problem solving.

Supplier Quality: (R) Responsible

• Work closely with the Purchasing team to support in the management of suppliers. This will include supplier approvals and audits, quality reviews and quality metrics reporting (KPIs).
• Obtain evidence of corrective actions from Suppliers.
• Follow-up on corrective actions to ensure they implemented on time and are effective.
• Manage Material Review Board (MRB) meetings and liaise with Production related issues such as returns and reworks.
• Communicate reject details to the supplier and ensure return of rejected parts to the supplier.
• Manage Quarantine Warehouse (QT) transactions and stock-take.

General

• Assist in improving the culture of all staff in the regulatory and quality assurance requirements relating to medical devices.
• Where necessary; collating and analyse performance data and charts against defined parameters.
• Help establish standards of service for customers and clients.
• Plan workflow through the department to ensure timely delivery of all projects.
• Responds and resolves general quality issues.
• Complete training in accordance with company procedures:
  • To always portray a professional and ethical image.
  • Promote quality within the organisation.
• Assist in developing and conducting internal training programmes to promote the awareness of the importance of regulatory issues to other departments, as appropriate.

General Management Requests

• Complete tasks as assigned by Line Manager / Supervisor in a timely manner.
• General support and assistance in technical or other matters of expertise as and when required.