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An exceptional opportunity for a GLOBAL MARKET GROUP QUALITY LEAD (EUROPE & AFRICA) with a global manufacturing organisation specialising in the manufacture of an impressive portfolio of fast moving consumer goods/over the counter products.
The GMG (Global Market Group - Export) is the fastest growing area of their business and this position is presented on a fixed term contract basis for 12 months with an exceptional package available for the right person and also offers attractive hybrid working.
The Role:
Reporting to GMG CoE (Centre of Excellence) - Quality Head. EA (Europe & Africa), Business & Product Quality Head is the technical expert in quality requirements, standards, and best practices in one of more regulatory classification areas.
The Position:
This position is responsible for quality oversight of new product launches, and product changes, ensuring to maintain high quality and applicable compliance. This position will work closely with EA Commercial Team, R&D, Regulatory, Analytical, Manufacturing Plant Quality and Operations to support the on-time launch of new products and changes and influence these functions in the development of a new product quality plan and change control documents. The position is also a major contributor to issue resolution utilizing quality engineering skills to ensure on-time commercialization.
This position leads the Business & Product Quality to achieve compliance to the MDD/MDR, MHRA, ISO13485, Quality System Regulation (QSR) and/or other quality system standards as required. Functions as point of contact for Business & Product in GMG Europe and Africa business. Establishes, maintains, and operates systems to measure, assure and improve the local QMS.
Key Responsibilities:
Ability to work with all levels of EA Commercial Team, PD, Supply Chain, Technology teams to build relationships across functions.
Strong execution skills.
Ability to think strategically and creatively translate strategy into action.
Demonstrates agility and connectivity across the organization.
Actively builds connections and partnerships with others, internally and externally.
Responsible for Quality and compliance for EA Business, adhering to company corporate policies.
Responsible for oversight of the Quality Management System for all EA Business, products, and services, including report outs of the adequacy and needed changes based on monitoring, metrics.
Escalates quality issues to Quality Management for review and appropriate action.
Oversees implementation to ensure adherence to new requirements.
Establishes and maintains system for and audit compliance with MDD/MDR, MHRA, ISO 13485 and current Quality System Regulation requirements. Completes all documentation, tracking, and follow-up requirements as necessary. Acts as lead auditor during audits.
Assesses measurability and effect on end user satisfaction of product designs and changes. Leads investigation of root causes of product-related customer complaints.
Instructs others in quality and measurement methods.
Responsible for managing and following quality system procedures. Ensures product quality and takes appropriate action when non-conformances are identified. Maintains accurate records.
Conducts all activities in a fair, ethical manner which is in compliance with all corporate policies.
Skills & Attributes:
Standard quality and statistical methods, problem solving methods, process capability methods, sampling methods, fixturing/gauging principles and non-destructive testing methods.
Project and resource management and leadership.
Monitors progress by maintaining dialogue on work and results.
Responsible for oversight based on agreed to strategy.
Excellent verbal and written skills; able to analyse, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates issues to internal and external stakeholders, including Senior Management.
Ability to prioritize and to handle multiple projects simultaneously.
Ability to work with all levels of management and to build relationships across disciplines.
Education & Experience:
University degree in Engineering, Quality or Science.
Professional typically with over 8 years technical experience and a demonstrated track record.
Generalist in Consumer products and medical device
Contributions balanced between strategy and functional execution elements; independent; people management.
Understanding of MDD/MDR, ISO13485, Medical Device Regulations and MHRA Requirements.
Ideally has experience in application of Risk Management of medical devices.
Strong quality skills, including investigation and root cause analysis, statistics, sampling, test methods.
Strong communication and interpersonal skills. Experience in project and resource management.
Health & Safety:
To support safety as a top priority.
To ensure oneself and others is aware of, understands and follows all Company Health & Safety instructions.
To report any accidents or near misses to the Health & Safety Manager.
If you have the skills, knowledge and experience we are seeking then your application is warmly welcomed.
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