Quality Manager - Medical Devices

Prospero Engineering
13 Apr 2018
21 Apr 2018
Contract Type
Full Time
Prospero Engineering have a fantastic new Vacancy for a Quality Manager in the field of Medical Devices. The company boast a modern working environment and excellent benefits


The Quality Manager is responsible to plan, organise, lead and control Quality Management activities, balancing the strict requirements of the position with evolving business needs and supporting stakeholders. Also to ensure that systems and controls are in place to maintain safety of products, and compliance to all Quality System requirements.

Key Responsibilities

• To ensure that there is a QMS in place that satisfies the requirements of the relevant quality standards (including but not limited to ISO13485 and 21CFR820) ensuring that it matches business needs and satisfies the requirements of all target markets.
• To strategically create and implement the QMS Audit Plan based on immediate and longer-term business priorities, to ensure effectiveness of the QMS and ongoing improvement.
• To maintain a process of regular audit QMS in line with the QMS Audit Plan and report on status of effectiveness to company management.
• To implement improvements where necessary in collaboration with relevant stakeholders, to ensure the ongoing effectiveness of the QMS, provide mentorship and support to the company as required.
• Support of External Audit, ensuring audit priorities are clearly communicated and the internal resources are made available.
• Implementation of QMS Audit against Audit Plan to assure adequacy of the QMS, and reporting to Senior Leadership on conformance and effectiveness of the QMS, based on Audit findings.
• Communication of issues from audit, and escalations as necessary.
• Identification of action priorities based on Gap Analysis from Internal Audit.
• Documentation of action items, and resolution plans.
• Ensure adequate and timely closure of identified issues.

Tools Development
• To ensure that tools are in place to support effective work processes and conformance to the QMS.
• Definition, development and qualification of QMS tools to meet short-term and strategic business requirements.
• To train and mentor employees in the effective use of the QMS tools.

Quality Assurance
• To provide quality assurance support of design and development process, driving adherence to and efficiency of company procedures throughout the product development lifecycle for:
o Software
o Mechanical
o Electronic

Product Quality Planning
• Setup of Quality Plan for all Products
• Monitoring of delivery against Quality Plan
• Definition of V&V Plan for all products

Supplier Audit
• Definition of Supplier Audit Plan, based on business priorities
• Implementation of Supplier Audit against Audit Plan to assure adequacy of the Product Supply Chain, and reporting to Senior Leadership on conformance and effectiveness of the Supply Chain based on Audit findings
• Communication of issues from audit and escalation as necessary
• Identification of action priorities based on Gap Analysis from Supplier

• Documentation of action items and resolution plans
• To ensure adequate and timely closure of identified issues

Issues Management
• To define and implement an integrated issues management process with documented workflow, covering:
o Complaints / Adverse Events handling
o Engineering Issues Management
o Audit non-conformity handling
o Engineering Change

• To define and manage the workflow for the problem resolution, ensuring that there is common efficient handling of all issues for:
o Acceptance and assignment
o Management and resolution
o Escalation
o Closure
• To drive/manage the issue management process, maintaining regular reporting on status to company management.
Document Control
• Management of Document Administration Process
• Management of the Intellectual Property documentation archive

Key Performance Indicators (KPI’s)
• To ensure that a comprehensive set of KPI’s are defined, to measure performance of the company against agreed targets.
• To ensure that KPI’s are reported by the management team, that actions are identified to drive the necessary improvements and achieve the agreed targets.

Team Management
• To mentor direct reports, ensuring that there is a common agreement on strategy, priorities and deadlines and to maintain a strong understanding of delivery against plans and targets.
• Management and control of spend and programme delivery to match agreed outputs
• Management of team of quality engineers
• Agreement of Targets and Objectives with all team members

• Extensive experience working in product development and delivery
• Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multi-disciplinary development effort (mechanical, software, electronics, system integration, pneumatics, fluid mechanics etc.)
• Experience and capability in root cause analysis, leading issue investigation and resolution, documentation and testing
• Experience of working with requirements management systems, document management systems and issue management systems
• Experience in definition and qualification of tools in support of the QMS
• Familiarity with regulatory standards i.e. MDD (93/42EEC), ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304, 21 CFR 820, 21 CFR 807, 21 CFR 11
• Ability to operate and communicate at strategic and operational levels
• Ability to identify strategic and operational issues and develop plans to address
• Ability to lead; demonstrating assertiveness, team building and management skills

Please note all applicants must be eligible to live and work in the UK

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