R.T. Lane Recruitment

Initial 12-month contract role.

 Description:  

Provides quality technical and compliance expertise as part of teams tasked with establishing customer needs, developing new products and/or modifying existing designs. Assures compliance to applicable regulations and completes quality activities such as risk assessments, device testing, QMS/data audits, procedure development, documentation review and changes to controlled documents. Provides design control, risk management and compliance support for product design and manufacturing, corrective and preventive actions, product/process improvements and complaint investigations.

DUTIES & RESPONSIBILITIES

  • Responsible for ensuring company Design control and Risk Management activities, wherever they are performed comply with the requirements of the company Design Control and Risk Management processes.
  • Provides Quality support/guidance to R&D and Lifecycle Management projects leads/team members.
  • Resolves project issues by working with team members, suppliers, and others as appropriate.
  • Applies thorough, systematic problem-solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
  • Manages and maintains the records related to design control applicable to product development and design/manufacturing change projects.
  • Contributes and participates in design review meetings.
  • Provides input into the generation of risk management file documents; Risk Management Plan, dFMECA, pFMECA and associated reports.
  • Provides input into development of protocols / reports supporting the Design control process.
  • Provides input and review to protocols and reports for sterilization, biocompatibility and packaging validations.
  • Co-ordinates the timely review and approval of all details in R&D batch sterilization records as meeting the requirements of the cycle validated and appropriate for the company product.
  • Co-ordinates the review and approval of production records and sterilization records of product manufactured during the design control process to facilitate timely approval of Design reports.
  • Supports bench test activity as required.
  • Supports the translation of the design requirements into manufacturing requirements.
  • Ongoing monitoring of data from Quality Management systems and provision of immediate feedback to quality management on deviations or issues of concern.
  • Administration and management of company systems for CAPA, non-conformances and for supplier corrective actions.
  • Leads and/or facilitates compliance and improvement activities associated with the Quality System (e.g. CAPA).
  • Prepares data as applicable for use in management review.
  • Supports internal/Supplier audits as applicable.
  • Supports regulatory activities as requested by management.
  • Represents the company professionally and positively externally to agencies, vendors and regulators.
  • Responsible for communicating business related issues or opportunities to next management level.
  • Responsible for ensuring personal and Company compliance with all State, local and Company regulations, policies, and procedures.

EXPERIENCE AND EDUCATION

  • Minimum education of a level 8 degree in a technical field.
  • Minimum 2 years’ experience in the medical device industry and/or IVD/pharmaceutical preferably in a design quality role.
  • Knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes beneficial.
  • Knowledge of QMS requirements and processes.
  • Knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.
  • Ability to discern major quality issues.
  • Ability to work well under deadlines and pressure.
  • Ability to work on own initiative and as a team player.
  • Ability to build good, strong, and positive working relationships with cross functional teams internationally.
  • Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.

Maximum file size: 2MB