Cantel Medical

QA/QC Engineer

UK-Clevedon
Job ID
2017-3483
# Positions
1
Category
Quality / Regulatory
Cantel International

Job Overview

Manage the UK Quality System by assuring that the appropriate procedures are in place, being followed consistently and are in compliance with the regulations such as ISO and Health and Safety.
QA Compliance

Assist Quality Manager in ensuring compliance with QMS ISO requirements and conduct internal and supplier audits per agreed upon schedule, identifying opportunities for improvement providing clear recommendations to the business.

New Product Introductions
Work with management team to assure new products are registered in the appropriate markets and introduced into the marketplace in accordance with design control procedures.

Main Responsibilities

  • Assure quality system policy and procedures are properly implemented, maintained, adhered to and improved where necessary.
  • Ensure compliance with regulatory standards such as ISO (establish schedules and conduct audits) monitoring the regulatory standards for changes.
  • Manage and maintain the organisational Calibration process.
  • Manage and maintain the receipt inspection process in line with the organisational sampling plan.
  • Assure contract manufactures are in compliance to regulatory and quality system requirements where appropriate.
  • Assist Quality Manager to maintain AND IMPROVE Corrective & Preventive Action (CAPA) process.
  • Assist Quality Manager in managing the complaint handling process (including Adverse Incident reporting) by assuring that all complaints are properly documented, processed in a timely manner, and appropriate corrective actions are taken.
  • Assist with Product Withdrawal and Recall Process as required (FSCA and FSN).
  • Assure control and proper disposition of nonconforming products (perform MRB activities).
  • Manage return material processes maintaining clear audit trails and records.
  • Assist the Quality Manager to ensure that the facility is properly prepared FOR ISO Audits
  • Coordinate quality related corrective actions with third party business partners.
  • Assist Quality Manger with Supplier Quality Assurance activities and audits.
  • Assure new products are introduced into the marketplace in accordance with Design Controls and that all products are properly validated.
  • Proactively be part of the departments drive for continual improvement across all QA remits.

Qualifications

Experience and Technical skills:

  • Amount of Experience: Significant experience of Quality Assurance or engineering within medical device industry.
  • Experience in tracking and driving improvement in quality metrics through process or design changes.
  • Production QA (design) hands-on experience.
  • Approximately 25% travel required to visit UK customers & European suppliers

Personal attributes required:

  • Ability to build strong multi-functional relationships
  • Demonstrated ability to influence and drive change and policy implementation within a business.
  • Detail orientation and bias for action, along with self-starter working style. 

Education and qualification:

 

  • Education: BS degree in Electrical or Mechanical Engineering.

 

  • Supplier QA engineering hands-on experience, including audits.
  • Design control hands-on experience.
  • Knowledge of ISO9001, ISO13495 and Health and Safety standards.

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed