Collins McNicholas

Senior Quality Engineer

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution.

Essential Job Functions

  • Investigate complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
  • Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk. 
  • Develop, update, and maintain technical content of risk management files. 
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes. 
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work 
  • Train, coach, and guide lower level employees on routine procedures.

Required Education/Skills/Experience:

  • Proven expertise in usage of MS Office Suite; CAD experience preferred
  • Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
  • Working knowledge and understanding of statistical techniques
  • Previous experience working with lab/industrial equipment required
  • Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
  • Strong problem-solving, organizational, analytical and critical thinking skills
  • Substantial understanding of processes and equipment used in assigned work
  • Good leadership skills and ability to influence change
  • Knowledge of and adherence to Quality systems
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)

Comment

In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Med Tech Report | Collins McNicholas

A new report shows that Ireland’s medical technology sector employs over 32,000 people, hosts 18 of the 25 largest Med Tech companies in the world, and has €12.6 billion worth of exports annually, making Ireland the fifth largest exporter in Europe. Ireland develops some of the most sophisticated products in the industry, with particular strengths in high […]
Read More