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Quality Systems Engineer (Quality and Engineer + HNC + Manufacturing +

Eingestellt von Larson Group

Gesuchte Skills: Engineering, Engineer, Support

Projektbeschreibung

QUALITY SYSTEMS ENGINEER

Quality and Engineer + HNC + Manufacturing + QA + Quality + SPC or AQL or FMEA or ISO 9001 + FDA or QSR or CGMP

ROLE: QUALITY SYSTEMS ENGINEER

TYPE: CONTRACT

LOCATION: BEESTON, LEEDS

DURATION: 6MONTHS +

EXPERIENCE

HNC or Engineering degree

- 5 years engineering experience, ideally have served an engineering apprenticeship
- Must have an engineering background in manufacturing, with a proven ability to interpret and create engineering specifications and procedures
- Should have QA Engineering experience, and awareness of quality systems and techniques such as SPC, AQL, FMEA,ISO9001 and FDA QSR's and CGMP's
- CMM operating and programming experience - Gauge design and a good understanding of geometric tolerance would be a distinct advantage
- Must be PC literate, and familiar with MS Office applications.

POSITION RESPONSIBILITIES

- Produce and maintain appropriate and comprehensive quality process specifications as required during the development and implementation of new products. Quality process specifications to be compiled for onsite production and purchased for resale goods (Goods In Check procedures)
- Document and maintain in good order all relevant Quality assurance sections of Device Development History File (DHF) and Device Master Record (DMR) as directed by Document Control
- Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed
- Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
- Produce automated verification solutions - train/certify personnel as required
- Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
- Support adequate product specific microbial assurance activities via appropriate liaison with Microbiologist and product packaging group.
- Ensure compliance with all Documented Quality system, FDA QSR's and ISO 9001 requirements during day to day and assigned audit/CAPA activities
- Develop and implement Quality planning as directed to demonstrate and realise a continual improvement in product and service quality
- Monitor and establish reject and rework rates as directed. Report on these issues, and identify trends and appropriate corrective actions.

NON-ESSENTIAL FUNCTIONS:

- Maintain a good level of housekeeping in designated areas, and observe all Health and Safety at work requirements.
- To operate within the company's standard operating procedures where applicable, and review, maintain and create appropriate procedures for sphere of activity.
- Carry out problem analysis/complaint investigation as required, and define through negotiation effective corrective actions.
- Produce automated verification solutions - train/certify personnel as required

PERSONAL TRAITS:

- Well-developed organisational skills, with ability to work on own initiative. Good communication and presentation skills in order to effectively communicate technical and QA requirements to all functional departments and external facilities.
- Determined approach to problem solving, and ability to make appropriate decisions concerning product/process disposition and general Quality assurance procedural suitability.
- Ability to deal with flexible workload and type is essential, and also an ability to work productively within a project focused team environment.
- Self-motivated and self-disciplined, must be able to work unsupervised and equally well as part of a team.
- Excellent written and oral skills
- Result driven
- Excellent social skills
- Team player
- Able and willing to work in a complex organization with highly detailed rules and regulations
- Computer literate

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Larson Group