Job Details

Quality Engineer II

North America, USA, Ohio, Dublin
Job Reference
Job Function
Reg Affairs & Quality Assurance
About Us

Smiths is always looking for curious minds. For new colleagues who want responsibility and relish a challenge. Those who would like to use their talents to help make the world safer, healthier, more efficient and more connected.

We're proud that we've been helping propel the human world forwards during our 160 year history of innovation. By looking at things differently. By adapting and never standing still. And by always thinking big.

Today we're an aligned global business of five divisions and around 22,000 colleagues, that touches the lives of millions every year across five vibrant global markets.

In Smiths Medical, one of the five divisions of Smiths Group, we touch the lives of millions of people every day. Our colleagues are focused on providing innovative, lifesaving solutions for patients around the world.

So whether you're an experienced professional or just starting out on your career, our global scale and focus on growth means great career opportunities for the right colleagues. There's never been a better time to join Smiths. And help us create the future.

Job Description

Smiths Medical is currently hiring a Quality Engineer II in Dublin, OH.

The Quality Engineer II will support and drive continuous improvements of quality systems and manufacturing processes, including CAPA investigation and solution activities. This role will also help drive quality activities related to continued compliance to changing regulatory requirements.

Smiths Medical has a positive impact on someone’s life around the world every minute of every day.  In fact, over 240 people every minute benefit from a Smiths Medical product. Join us and grow your career while being a part of our continued success! We offer a fun, fast-paced, inspiring and collaborative work environment with opportunities to learn and contribute at all career levels.  Innovation is part of who we are, with industry-leading products across a broad spectrum of medical device categories and a strong new product development pipeline. 

Duties & Responsibilities
  • Conducts engineering activities of intermediate scope or degree of difficulty. This could include medium – large components/system, processes associated with a medium or large project.
  • Performs assignments independently with limited supervision as to expected results.
  • Performs assignments independently troubleshooting tasks as related to product problems.
  • Prepares documentation associated with engineering activities.
  • Coaches and helps develops entry level engineers.
  • Determines resolution of intermediate technical issues as needed and assures that technical work meets specified requirements.
  • Contributes to corrective action development and alternatives.
  • Supports and drives continuous improvements of quality systems and manufacturing processes, including CAPA investigation and solution activities.
  • Drives quality activities related to continued compliance to changing regulatory requirements.
  • Supports manufacturing activities related to supply continuity.
  • Provides expertise in representing the quality operations function on a cross-functional project team.
  • Develops incoming inspection and in process test methods and validation plans.
  • Develops best practices for quality system processes.
  • Creates and maintains product device master record documentation.
  • Coordinates and support multi-site project tasks.
  • Writes technical documents including test protocols and reports.
  • Understands and follows requirements of SOPs.
  • This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site.
  • Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement.
The Individual
  • 4 year degree in engineering or similar required.
  • 3-6 years of experience or 1-3 years with an advanced degree
  • Understanding and wide application of technical principles, theories and concepts in the engineering field.
  • General knowledge of the disciplines (Regulatory, Quality and Operations).
  • Intermediate problem solving and analytical ability.
  • Ability to critically review and interpret technical documentation.
  • Ability to exercise judgement in making preliminary selections and adaptation of engineering alternatives.
Salary & Benefits

In addition to a competitive compensation package, Smiths Medical offers a comprehensive benefit package including Medical, Dental, Vision, 401K and much more!

Diversity & Inclusion

We believe that different perspectives and backgrounds are what make a company flourish. All qualified applicants will receive equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, economic status, disability, age, or any other legally protected characteristics. We are proud to be an inclusive company with values grounded in equality and ethics, where we celebrate, support, and embrace diversity.

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