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Quality Engineer I - Exempt

Quality Engineer I - Exempt

LanceSoftMounds View, MN, United States
7 hours ago
Job type
  • Full-time
Job description

Join our team in Mounds View, MN, where you will be part of a dynamic environment focused on innovation and quality in the field of cardiac surgery perfusion products. We are seeking a dedicated individual to contribute to our mission of advancing technology and ensuring the highest quality standards.

Must Have

  • Bachelor's Degree in Engineering, Science, or a technical field with 0 years of work experience in Engineering and / or Quality.
  • OR Advanced degree in Engineering, Science, or a technical field with 0 years of work experience in Engineering and / or Quality.

Nice to Have

  • Bachelor's or Master's Degree in Mechanical Engineering, or other related engineering degree strongly preferred.
  • Experience in medical device design and application of test standards.
  • Experience in applying statistical methods to design reliability and process capability.
  • Certified Quality Engineer, Reliability Engineer, or equivalent desired.
  • Strong oral and written communication skills.
  • Effective team player with cross-functional collaboration skills.
  • Excellent presentation skills.
  • Ability to handle multiple tasks / projects and manage priorities accordingly.
  • Working knowledge of appropriate industry standards.
  • Ability to work in a team environment and exert influence without alienating others.
  • Knowledge / basic understanding of specification development, industry standards, geometric dimensioning and tolerancing (GD&T), etc.
  • Responsibilities

  • Develop, modify, apply, and maintain quality standards and protocols for processing materials into partially finished or finished materials product.
  • Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
  • Support post-market quality activities including complaint trending, released product manufacturing and design changes, CAPA support, complaint investigations, real-time age testing, and statistical analysis.
  • Ensure corrective measures meet acceptable reliability standards and documentation is compliant with requirements.
  • May specialize in areas such as design, incoming material, production control, product evaluation and reliability, inventory control, and / or research and development as they apply to product or process quality.
  • Technical Specialist Career Stream

    An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers, and / or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies - from design to implementation - while adhering to policies, using specialized knowledge and skills.

    Differentiating Factors

  • Autonomy : Entry-level individual contributor on a project or work team. Works with close supervision.
  • Organizational Impact : Delivers work of limited scope, typically smaller, less complex projects or related activities.
  • Innovation and Complexity : Identifies, defines, and addresses problems that are not immediately evident but typically not difficult or complex. Makes minor changes in systems and processes to solve problems.
  • Communication and Influence : Communicates primarily with internal contacts within the immediate group. Contacts others to gather, confirm, and convey information.
  • Leadership and Talent Management : N / A - job at this level is focused on self-development.
  • Required Knowledge and Experience : Requires broad theoretical job knowledge typically obtained through advanced education. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A)), 0 years of experience required.
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    Quality Engineer • Mounds View, MN, United States

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