Quality Manager

Direct Appointments
13 Apr 2018
21 Apr 2018
Contract Type
Full Time
Quality Manager - Medical Devices/Pharma/Life sciences/ Healthcare
Salary £Excellent + 10% Bonus (£7K) + Shares + Car

Our client is looking for a permanent Quality Manager to be based at their headquarters near Warwick and Birmingham.

Reporting to the Director of Quality and Regulatory Affairs, our client is looking for someone who is a proven Quality management professional, and great at leading people within a medical device manufacturer or either from Healthcare, Pharmaceutical or life science sectors.

As a Quality Manager you will be 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 Company products, and compliance to all Quality System requirements.

Key Responsibilities of the Quality Manager will include:

QMS Requirements:

• Implement a QMS system that satisfies the requirements of the relevant quality standards (including but not limited to ISO13485 and 21CFR820) ensuring that it matches business needs
• 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.
• Maintain a process of regular audit QMS in line with the QMS Audit Plan and report on status of effectiveness to company management.
• Support of External Audit, ensuring audit priorities are clearly communicated and the internal resources are made available reporting to Senior Leadership on conformance and effectiveness of the QMS, based on
• Identification of action Audit priorities based on Gap Analysis from Internal Audit.

Quality Manager Requirements/Qualifications:
• Proven experience of working in product development and delivery environment
• 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
• 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 – an advantage

When submitting your cv please detail your £current and £expected salary requirements

Referral Fee:
Due to a number of roles being required by our client - If a candidate is referred by an individual and is successfully appointed a fee of £1,000 will be paid to the person making the referral.

In return, you can expect a very £competitive salary, superb career opportunities and personal advancement as the company is growing exponentially and possesses a work based culture that any employer in this sector will be hard pressed to beat.

Direct Appointments Limited provides permanent, fixed term and interim recruitment services to a wide range of clients in a number of sectors. We source exceptional talent and deliver a robust, value added approach to every campaign we undertake; connecting the right high performance people to the right career option

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