Quality Engineer I Jobs

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.

We are currently looking for a Product Quality Engineer I to join our team. As a Product Quality Engineer I, you will contribute to our mission by helping your department complete key projects. At Olympus, Product Quality collaborates with R&D, Regulatory, Medical and Manufacturing to support Medical Devices during the entire lifecycle with strong focus on new development. You will work in a cross-functional team to support Risk Management of Medical Devices and will help us in our goal to continuously improve products and patient safety.

Experiences that grow you—and your career.

Job Duties

• Product Support: Help to develop solutions to technical problems which require the regular use of ingenuity and creativity.

• Assist in the design and execution of the Product Development Process.

• Collaborate with project teams to define product requirements, support test method development and validation, and support Design Verification planning and reporting.

• Develop, implement, and update risk management deliverables (i.e. hazard analysis, risk considerations, FMEAS, risk management plans and reports, etc.) supporting new product development and sustaining efforts.

• Be involved in the execution of Quality Deliverables such as Project Design & Development Plans and Product Development Quality Plans.

• Support process and design related verification and validation activities.

• Help in the execution of the Risk Management deliverables to ensure compliance to applicable standards and regulations (including EUMDR) and demonstrate a primary commitment to patient safety.

• Be Involved in usability and design validation efforts for new product development and design change projects.

• Review and analyze complaint information to identify new failure modes, new harms, and/or trends.

• Work cross-functionality with project management, R&D, regulatory, manufacturing, and other quality functions.

Job Requirements

REQUIRED QUALIFICATIONS:

• Bachelor's degree in Mechanical, Electrical, or Biomedical Engineering.

• Up to 10% domestic travel

• Must possess excellent analytical and organizational skills.

• Must be proficient and have practical knowledge in Microsoft Word, Excel, and PowerPoint.

• Must be able to work well within a team and independently at times with limited guidance.

PREFERRED QUALIFICATIONS:

• Internship with a Medical Device company preferred but not essential.

• Demonstrated ability to balance academic and extracurricular commitments (i.e. work experience, clubs, volunteer activities, teams, etc.).

• Ability to thrive in a fast-paced, dynamic and deadline-driven environment.

• Self-motivated with the ability to prioritize/execute multiple concurrent tasks.

• Strong, professional communication skills.

• Skilled in presentation development and public speaking.

• General curiosity and a desire to learn new material.