Supplier Quality Engineer
Our client are a large Medical Device company based in Hampshire looking for a Supplier Quality Engineer
Previous Quality Engineering experience working in the Medical Device industry
The Supplier Quality Engineer position reports to the Quality Assurance (QA) Manager. This position provides Supplier Quality Engineering support with the goal to continuously improve product quality and reliability through evaluation and control.
Duties and Responsibilities
The job holder’s duties or responsibilities are not limited to those listed below. The job holder is expected to perform other duties and responsibilities as assigned by the QA Manager.
Assists QA Manager in establishing, implementing and maintaining the Quality Management System (QMS);
Supports engineering projects (as pertaining to the CFN 305 plant) by providing supplier quality engineering input pertaining to material and product transfers, cost reduction opportunities and sourcing initiatives;
Supports the development and implementation of sampling plans, statistical analysis, measurement, test and inspection procedures at suppliers;
Collects, analyzes (using statistically valid methods) and reports key (quality) performance indicators to key stakeholders (internal and external to the CFN 305 suppliers) and identifies areas for improvement (product design, manufacturing process, equipment and/or the QMS), initiates and lead continuous improvement projects by applying relevant methods;
Conduct supplier quality audits, including closing out audit findings, creating audit finding reports and determine proper corrective and preventive actions.
Conducts internal quality audits, including closing out audit findings, creating audit finding reports and determine proper corrective and preventive actions.
Handles supplier-related issues, ensures timely resolution of supplier failure, corrective actions and preventive actions, in matters related to component quality deficiencies;
Leads and/or supports process and/or product related failure investigations, establishes detailed failure investigation reports to faciliate timely implementation and/or closure of NCMRs, CAPAs and Customer Complaints;
Key team member for Product Focus Teams (PFT), supporting and promoting QIT activities, and operational excellence projects.
These are only minimum qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need.
Basic engineering degree proven quality engineering experience within the medical technology industry or equivalent, or equivalent combination of education and experience;
ASQ or IRCA Lead Assessor Certification preferred;
ASQ CQE certification preferred;
SPECIFIC SKILLS & ABILITIES
Sound knowledge of ISO 13485 and Medical Device Directive 93/42/EEC requirements;
Good written and oral communication;
Good prioritizing, organization, interpersonal, communication and analytical skills;
Work independently with minimum supervision, across multiple geographics and functions;
Sound knowledge of statistical techniques (Gage R&R, Acceptance Sampling, Process Capability, Statistical Process Control),
Sound knowledge of failure investigation techniques (8M, Cause and Effect Analysis);
Good computer skills (MS Office);
Basic knowledge of lean methods (5S, Lean Six SigmaSS, Kaizen) prefered;
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists;
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form;
Basic knowledge of US FDA 21 CFR 820 requirements preferred;
To apply for this position, candidates must be eligible to live and work in the UK