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Quality Engineer - Senior (1748) - UK

Quality
Ref: 244 Date Posted: Tuesday 30 Oct 2018
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Are you a Quality Engineer Looking to Lead a Team?
 

Duties & Responsibilities (leadership, people development, planning and execution)

• Lead the quality activities for all product and process validation activities for all the company. Develop and maintain state of the art protocols and procedures and ensure correct implementation across site. Provide technical expertise for all areas on relevant IQ/OQ/PQ protocol issues. Maintain and lead the Site validation master plan

• Lead site wide activities aimed at maintaining Part 11 Compliance.

• Lead Quality Engineering effort for all manufacturing processes. This will include managing projects designed to identify and implement process improvements within the area.

• Provide the Quality effort for all New Product Development activities to ensure that all Quality aspects of process design are addressed. Document and maintain in good order all relevant sections of Device Design History File and DMR as directed.

• Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity. Work with Production and Technical Support to develop and implement appropriate process control plans.

• Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated products and components are compliant.

• Partner with Supplier Quality, Technical Support, Design QE and Purchasing to ensure that all Supplier generated design changes managed and documented in a compliant manner. • Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 13485 requirements during day to day and assigned audit/CAPA activities.

• Maintain a good level of housekeeping in designated areas, and observe all Health and Safety at work requirements. Operate within the company’s standard procedures where applicable, and review, maintain and create appropriate procedures for sphere of activity

 

Job Specific Competencies

• Ability to communicate & present (in all its forms) and co-operate effectively at all levels across the organization.

• Well developed organizational skills and people development skills.

• Attention to detail and excellent time management.

• The ability to work to a deadline, to cope under pressure and react to changing requirements.

• The ability to work as part of a team to achieve results

• An effective leader of the QE team with relevant experience in all areas within the QE role

• Manage personal workload and assist the wider group in managing conflicts and Bottlenecks

• Team performance management on regular basis

• Proactive leader

 

GLP Competencies:

Credo Values: Integrity & Credo Based Actions

Customer Focus: Results & Performance Driven & Sense of Urgency

Innovative Solutions: Big Picture Orientation with Attention to Detail & Intellectual Curiosity Talent Development: Collaboration & Teaming & Self-Awareness & Adaptability

 

Education

• Minimum educational level of Degree Level (or equivalent) in a relevant science discipline. Experience

• Minimum of 7 year industry (relevant) experience in a science based discipline or a minimum or 10 years experience in a quality related role.

 

Experience

• Minimum of 7 year industry (relevant) experience in a science based discipline or a minimum or 10 years experience in a quality related role.

 

Personal Attributes

• The role requires an experienced technically skilled individual.

• Good interpersonal and communication skills with proven people management ability

• Flexibility, efficient, organized and results focused leader

 

This function involves a close working relationship with the following Departments:

• Quality functions

• NPD

• Technical Support

• Purchasing

• Stores

• Logistics

Production

To further ensure that the quality of CMW products is maintained.

 

Specific Technical Skills

Essential

• Demonstrable high level knowledge of product and process validation including Part 11

• Sound knowledge of cGMP and regulatory standards. Must be experienced with working within a regulated environment; a working knowledge of ISO9001, ISO13485 and / or FDA Quality System Regulations would be an advantage.

Desirable

• Ideal candidate will be a Black belt or have experience in the use of SPC techniques, Gage R&R, First Article Inspection etc.

• Ideal candidate will have a polymer processing or chemical engineering background with a proven ability to interpret and create specifications and procedures.

• Knowledge of the medical device (or closely-related, healthcare, etc) industry

 

If this sounds like you and a role you would be interested in you can read the job spec or contact us at:
recruitment@medicalengineers.co.uk Or call us on:01612600190

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