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Home > Life Sciences > Supplier Quality Engineer

Job Reference: HH/HQ1246

Supplier Quality Engineer

  • Gloucester, Gloucestershire, England
  • Permanent / Full Time
  • Steven Jeffers
  • £30000 - £40000

Job Title: Supplier Quality Engineer         

Department: Quality

Reporting to: Product Quality Manager

Responsible for team of: Not applicable

Key purpose of role:

Responsible principally for supplier quality management activities. Supports the QA lead in the management of the company’s environmental monitoring process. Assists

the Product Quality Manager and QA Lead in quality control, batch release, complaints and vigilance, new product introduction and product and process change.

Responsibilities of the role:

Supplier Quality Management

  • Works closely with the Procurement team to establish supplier quality performance criteria and monitor supplier performance
  • Oversees the completion of Supplier Corrective Action Reports (SCARs)
  • Creates and manages a risk based supplier audit programme, ensures all audits are performed in accordance to the programme.
  • Performs supplier audits (FDA 21 CFR 820, ISO13485, ISO 9001)
  • Negotiates quality technical agreements with suppliers.
  • Creates and maintains component specifications with suppliers.
  • Manages the quality aspects of the Post Market Surveillance process

Product Quality

  • Investigates nonconformities and product complaints to resolve quality concerns effectively and within set timeframes. Uses root cause analysis tools and implements effective corrective and preventive actions
  • Supports the environmental monitoring program.
  • Collates and analyses performance data
  • Reviews and approves change requests
  • Provides support to validation activities, where required.

Promoting our Quality Culture

  • Maintains and follows all site Quality Management System (QMS) and regulatory requirements that can affect the quality of products, processes, or services provided to our customers.
  • Promotes and leads quality achievement and performance improvement across the organization.
  • Analyses data and reports to Senior Management at the Management Review, Qualify Objectives meetings and other forums as necessary.
  • Writes technical and management reports
  • Performs internal audits
  • Supports audits by customers and regulatory bodies. Acts as subject matter expert for subjects within their remit.
  • Supports the departments in other areas as required by the QA lead.

Qualifications

Essential

  • Degree in life sciences, engineering or equivalent
  • ISO 13485 Lead Auditor qualification

Competencies

Essential

  • Practical experience as ISO:13485 lead auditor.
  • Experienced in supplier auditing, including managing supplier non-
  • conformances and CAPAs to completion.
  • Effective written and verbal communication skills in the area of technical/clinical applications.
  • Ability to review and draw conclusions from data on complex subjects
  • e.g. technical documentation, scientific literature.
  • Effective analytical and problem solving skills.
  • Ability to coordinate and lead multiple projects simultaneously.
  • Capacity to anticipate and solve upcoming problems.
  • Strong interpersonal skills to ensure ability to work and interact effectively with internal and external customers.
  • Working knowledge of statistics and statistical methods.
  • Excellent communication skills.
  • Competent with standard office software, including computerized
  • databases for the maintenance of scientific data.
  • Fluent knowledge of English, both written and spoken.

Desirable

  • Experience in microbiology.
  • Knowledge/experience of orthopaedics.
  • Experience of supporting audits by regulatory bodies.

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