Product Development / Design Control Coordinator

PRODUCT DEVELOPMENT / DESIGN CONTROL COORDINATOR

We are an innovative medical device company that manufactures, distributes and markets high quality, innovative surgical devices – from niche to proprietary to fast moving consumables surgical device instruments – for minimally invasive and open surgery.

Roles and Responsibilities

  • • Fulfil Project Management Role along with Manager for a distinct set of clients by serving as secondary client contact for QA Manager, translating client needs into a defined scope of work, and working with QA Manager, Product Development and Design Control Manager and Management Team and effectively complete client deliverables.
  • • Implement processes and procedures and conduct analyses to sustain and improve the Quality Management Systems in relation to ISO: 13485. Examples include risk planning, analysis, design controls, verification and validation, and inspection methods and procedures.
  • • Work along side your Manager to develop and maintain company design history files (DHF) and Technical Files for all products and meet CE and FDA standards.
  • • Conduct post-market surveillance activities and liaising with the Quality Assurance and Regulatory Affairs Manager in customer complaints handling, MDR evaluations, and CAPA assessments.
  • • Responsible for effectively communicating with vendors inclusive of Contract Manufacturers and Distributors and achieving project deliverables for devices (e.g. design transfers and launch of new devices to be registered).
  • • Supporting Top Management and consulting group in the development and implementation of Quality Objectives and project deliverables.
  • • Use creative problem solving skills to identify, solve, and/or improve process anomalies.
  • • Work with suppliers, laboratories, manufacturers, and other group members to assist with implementation and effectiveness of product/project deliverables.
  • • Work with Manager and Vendors to generate Technical Files and implement document controls and transfers.
  • • Maintain both soft and hard copies of all data, procedures, and test protocols/ reports for accuracy and technical application of standards (ISO: 13485).

Knowledge, Experience and Expertise:

  • • Thorough understanding of Medical Device Industry.
  • • Thorough understanding of ISO: 13485 and Regulatory.
  • • Thorough understanding of managing projects.
  • • Effective management of projects.
  • • Communication and negotiation.
  • • Understanding of a multi-faceted business operation.
  • • Planning and forecasting.
  • • In depth knowledge of markets and changing business environments.
  • • Complex problem solving.
  • • Effective decision making.

Key Work/ Behavioral Competencies:

  • • Must demonstrate competence in the medical device quality system regulations and ISO: 13485.
  • • Able to apply quality tools techniques such as: design controls, quality system auditing, inspection methods, statistical sampling plans, gauging studies, design verification and validation, and process validation.
  • • Ability to apply mathematical concepts such as statistical inference and probability.
  • • Ability to apply logic, creativity, and scientific thinking to a wide range of intellectual and practical problems.
  • • Project management and liaise with all relevant internal and external key stakeholders.
  • • Demonstrates ownership for the integrity of work.
  • • Able to work independently and consider options for completing work.
  • • Strong written and verbal communication skills.
  • • Working knowledge of FDA regulatory premarket notification processes and labelling requirements.
  • • Must be able to manage projects and work with team members to complete tasks on time and within budget.

Professional / Tertiary Qualifications:

  • • Minimum 1-2 years’ experience.
  • • Significant experience in medical device industry and Quality Management System standards and meeting regulatory requirements.
  • • Experience of building a project plans and project management.
  • • Experience supervising and managing staff.
  • • Significant experience in product development and risk management.
  • • Demonstrated leadership skills and the ability to manage and communicate in a diverse workforce.

Please email your resume and cover letter to careers@theorcompany.com to apply.

 

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