Senior PQE

Job Ref: J30023
Sector: Engineering
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 28 January 2019
  • Hawarden, Flintshire, Wales, UK UK CH5 2NU
  • £35,000 - £45,000 per Annum
    ANNUM
  • Laith Mustafa
  • 0161 868 2231
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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Senior Product Quality Engineer - 35-45K (DOE)- Chester

Our client creates medical devices for the management of chronic conditions and infusion devices.

Job Summary

Managing projects that support design & development as well as supporting the maintenance of Design Controls throughout the product lifecycle.

Duties and Responsibilities

* Representing Quality Management, actively contributes to the development of New Products within the new product development process. Responsible for ensuring that Design Control requirements including development of Design and Development plans meet regulatory and applicable procedural requirements. Responsible for reviewing and approving design control document outputs. Works closely with Manufacturing QE's to assure appropriate Validation Planning and a robust Design Transfer. * Uses technical and GXP knowledge to influence and assure Quality and Compliance in Design and develops plans for Post Launch / lifecycle management activities. * Provides leadership as subject expert in Design Control and actively supports and influences development teams in the translation of User Needs to Design Inputs, Design Outputs, Design Verification and Design Validation activities, and timely Design Reviews. Develops and assures that Quality Control Plans are complete and meet the standards and requirements appropriate for the type of product. * Champions Risk Management activities through leadership, facilitation and active support during Product Development, and Post Launch Change Control activities. Demonstrates courage to drive Risk Management in decision-making to determine sound and timely decisions that balance compliance, business and product performance.* Responsible for Post Launch Reviews. Investigates product / process performance issues and leads or participates in multifunctional evaluation of products in the market. Evaluates data using statistical tools. Leads or support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). Leads or actively supports Product Change Control.* Takes responsibility for the measuring and monitoring of performance against agreed KPIs. Collates and shares information / data through reports and follows up on identified improvement opportunities. Actively participates and / or drives site /Company wide Quality System improvements as required.

This position requires some Domestic and International travel to be undertaken, which will necessitate overnight stays.

Education/Experience/Qualifications

Requirements:

* Degree or proven experience in science / engineering. * Experience gained within a Regulated Industry, preferable Medical Devices. * Demonstrated knowledge of Regulatory and GXP Compliance requirements such as QSR Part 820, MDD 93/42, GMP Parts 210 and 211, ISO 9001 / ISO 13485. Good knowledge of Design Controls.* Demonstrated knowledge and experience of Risk Management and the application and use of Risk Management Tools such as FMEA, Process Mapping, Hazard Analysis. ISO 14971* Experience with Quality tools such as Quality Control Plans, Test Method validation and transfer, Statistics, Design of Experiments, Root Cause Analysis, Process validation, Process Optimization. * Demonstrated ability to analyze and interpret complex problems / data gathered from a variety of sources and utilize.

Desirable but not required:

* Six Sigma knowledge, experience and certification.* Experience of plastics, extrusion, injection moulding, assembly, bonding.* Statistical tools (e.g. Minitab)

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
27/02/2019 14:47:13
GBP 35000.00 35000.00.