Company: Hydrogen Group
Closing Date: 29 Dec 16
Salary (£): Negotiable
Our clinet is a global leader that designs and contract manufactures components and finished products sold into the commercial, drug-delivery and medical device market. The company is recognized by its clients in over 40 countries for its expertise in product design, in-house tool making, injection molding, welding, assembly, packaging and sterilization. For them to respond to increasing demands of a rapidly growing business, we are looking for a strong and experienced Senior QA engineer.
The Senior Quality engineer can support the growth and development of the Quality Assurance organization and assure a permanent state of quality compliance. Quality and Compliance activities from the Senior Quality engineer are on an operational and tactical level. For both the production and pre-production organizationl. The Senior Quality Engineer is if necessary a back-up for the Quality Manager related to Metrology.
Key Responsibilities for the Operations Manager are:
Leadership & Production strategy
* Lead or participate in (quality improvement) projects;
* Develop trainings and train employees with regard to quality and improvement subjects;
* Coordinate the QA-activities.
* Sustain and set-up a Quality Assurance organization including adding new (innovative) capabilities to meet changing and increasing customer needs.
* Generate, review and authorize Quality related documents;
* Maintain the CAPA (Corrective and preventive actions) system;
* Maintain the complaint handling system
* Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action;
* Analyze data concerning production, processes and the quality management system and propose improvements
* Release products, processes and equipment based on statistical data;
* Execute internal and external audits including reports.
* When requested, accompany Customer and Regulatory Body Auditors
* Communicate results of of the KPI’s and quality goals to the Quality Manager.
* Act as a strong team-builder both with (in)direct reports (when applicable) as well as the peer-group and quality team
* Show professional can-do attitude towards the internal as well as the external organization and develop (in)direct reports (when applicable) into the same direction.
* Internal: All departments of Phillips-Medisize.
* External: Global organization, customers and suppliers.
Knowledge, Skills and Experience:
* Bachelor Level or Master Degree in Technical discipline
* Coaching and Management capabilities
* Good Manufacturing Practice
* Quality Management Systems (ISO13485. FDA 21CFR820, MDD 93/42EEC or similar)
* EO sterilization
* Cleanrooms/ microbiology
* Process validation
* Knowledge of Lean Six Sigma tools and project management
* Organized and structured way of working
* Good presentation/communication skills in English and Dutch
* Customer focused and accurate
* Good judgement; showing business acumen, quality, perspective and problem solving.
* Thinking in solutions, socially skilled.
* At least 5 year professional experience
* Experience in Leading a Team and Auditing
* Experience in Regulatory and Customer focused organization
* Experience in a Pharmaceutical and/or Medical Devices company.
30 Eastcheap London
|Tel:||+44 (0) 207 002 0000|
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