Engineering & Production Jobs In North West

JOB PURPOSE

To ensure that the the client’s business is compliant with all applicable regulatory and corporate requirements. This will be achieved through a combination of management of the electronic Quality Management System (eQMS), policy development, training and QMS audits.

PRINCIPAL ACCOUNTABILITIES

Quality Management System Management
1. To be the eQMS expert within THE CLIENT’S.
2. To ensure maintenance of business based support for the system and processes within the QMS to ensure ongoing compliance and validation.
3. To provide routine and non routine key performance indicators for the system and process’s within the system.
4. To carry out ad hoc reports and support as necessary.
5. To manage the team supporting the system.
6. To support system updates and projects as necessary.
7. To assist in providing independent quality representation for validation of THE CLIENT’S Global computer systems as required.
Policy Development and Deployment
1. Maintain a comprehensive understanding of current THE CLIENT’S and relevant regulatory requirements, including specific standards and requirements of electronic systems.
2. From this knowledge, support the continued development of the corporate Quality Management System, within the overall THE CLIENT’S Business Management System.
3. Conduct periodic reviews for adequacy of policies and procedures with experts across all business functions that represent key stakeholders in the QMS processes.
4. Assist the business in the strengthening of the individual procedures and working practices that comprise the eQMS, in order to meet the requirements of the Corporate Quality Manuals.
5. This assistance will involve supporting specific business initiatives from a quality perspective aimed at strengthening relevant systems e.g. management review, consumer services, change control and computer validation.
6. Advise all functions of the business regarding eQMS compliance.
Audit
7. Perform risk-based audits across the product lifecycle including: R&D, manufacturing facilities, warehousing & distribution centres, laboratories, core business systems and 3rd party contractors to confirm compliance with local and regional standards. These audits are required to an equivalent standard of a Regulatory Authority.
8. Assess risk and compliance in the above facilities and agree CAPA and timescales with area/functional management.
9. For audits of 3rd party operations, the job holder is required to recommend the 3rd party for approval for use by THE CLIENT’S (or not) and may be the only quality representative. This is a significant decision and will require skilled, risk-oriented judgement to determine compliance with Regulatory and THE CLIENT’S standards. The scope and any limitations of an approval have to be made clear to the business.
Training
1. To ensure users are trained to the appropriate level for the processes within the QMS.
Standards Management
1. Ensure that all documentation relating to processes within the eQMS are created and maintained to relevant levels of Good Documentation Practise and internal documentation standards.
Interface With Other Functions
1. In order to manage the eQMS it is necessary to interface with functional experts at different levels across all business functions; these stakeholders include: R&D, Regulatory, Medical and local business units.
2. Support all users of the eQMS in a consultative capacity regarding aspects of the QMS to continually improve quality and compliance.
3. Work with other Global Quality team members to ensure a harmonised approach and deputise as appropriate.
4. Present evidence of compliance to Regulatory Inspectors for areas of own responsibilities if required.

KNOWLEDGE AND EXPERIENCE
• Scientific background: likely to have a degree and/ or professional membership.
• At least 5 years experience working in the Healthcare, Personal Care, Medical Device or other Healthcare related industry.
• Very strong IT literacy.
• Proven and strong training ability.
• Good understanding of regulatory requirements relevant to the THE CLIENT’S portfolio of products and electronic systems (GAMP).
• Strong auditing skills/qualifications with a comprehensive understanding of key pharmaceutical processes, validation, facility and service requirements.
• Strong understanding of cGxP requirements relevant to regulated products THE CLIENT’S portfolio e.g. GMP, GCLP, GWP, GPvP and GDP.
• Influencing skills in areas with no direct reporting authority
• Commercial awareness and understanding of corporate codes of conduct
• Strong interpersonal and communication skills

This vacancy is being advertised by NCR (New Century Recruitment Ltd). The services advertised by NCR are those of an Employment Agency.

The right person for this role will have strong mechanical experience mixed with creative design. Please outline this in your application with a cover letter.

MAIN PURPOSE OF THE JOB

Mechanical Design Engineer working within a team ensuring products, customer projects and strategic business objectives are delivered to quality standards, on time and within budget. Proactively delivering quality improvements, cost reductions and lead time reductions in standard and application specific products.

REPORTING SUMMARY
Mechanical Design Manager

KEY ACCOUNTABILITIES

§ Plan and organise own daily & weekly workload to ensure delivery of weekly production targets and longer-term strategic business objectives.
§ Preparation of design proposals for bespoke applications.
§ Preparation of technical quotations
§ Producing estimates of product costs
§ Develop accurate bills of materials
§ Provide technical assistance to our clients Marketing Organisations and internal departments.
§ Develop, maintain and amend engineering design drawings using 2D and 3D software packages.
§ Prepare product test and validation documents.
§ Implement Engineering Changes accurately within required timescales.
§ Contribute to new product design, reducing costs and lead times by investigating and implementing new design techniques and manufacturing processes.
§ Investigate customer quality concerns ensuring that timely and effective corrective measures are implemented.
§ Responsible for carrying out risk assessments and advising safe methods of work.
§ Participate in and recommend continuous improvement activities.
§ Liaise with other departments to efficiently and effectively resolve problems.
§ Ensure safety, health and environment is inherent in all projects.
§ Promote, improve and maintain appropriate quality systems during the design process.
§ Identify own training needs and communicate these through to the Mechanical Design Manager.

This job description is not to be regarded as exclusive or exhaustive and you may be required to undertake various duties as reasonably be requested by the company.

This vacancy is being advertised by NCR (New Century Recruitment Ltd). The services advertised by NCR are those of an Employment Agency.

Our client calibrate and supply all makes of Electrical Test Equipment, 17th Edition, PAT Testers, Multimeters, and lots more.

They now seek Calibration Engineer to join their expanding team of engineers.

Testing electrical test equipment for correct function and accuracy.
Some experience would preferred. However full on the job training is provided.
Some background/knowledge in electrical/electronics would be helpful.
The job will involve 3 or 4 days per month of onsite work. This will involve taking a van with mobile calibration equipment to customer sites. Again full training will be provided.
This is a full time permanent position based in Trafford Park

Salary: £18,000 to £23,000.

This vacancy is being advertised by NCR (New Century Recruitment Ltd). The services advertised by NCR are those of an Employment Agency.