Quality Assurance Engineer

1 week ago


Cincinnati, Ohio, United States AtriCure Full time
About the Role

AtriCure is seeking a highly skilled Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality of our products and processes.

Key Responsibilities
  • Provide daily Quality Engineering support of manufacturing operations, working closely with cross-functional teams to address product line issues and implement correction and prevention processes.
  • Manage and coordinate activities related to daily operations, including NCRs, investigations, FMEAs, rework, deviations, and CAPAs.
  • Chair the Material Review Board (MRB) for respective product lines.
  • Apply reasoning ability to support and prioritize projects, adapt to shifting priorities, and resolve problems/conflicts.
  • Contribute to new product development and transfer by supporting Design Assurance and NPD Teams, including inspection/control plan development and establishment of compliant production and process controls.
  • Develop and implement quality system processes, including regulatory requirements, as applicable.
  • Assist with 3rd party, internal, and external FDA and ISO audits, as necessary.
Requirements
  • Bachelor's degree in Engineering or demonstrated equivalent combination of education, training, and experience.
  • 2-5 years of experience in a process, manufacturing, or quality engineering role.
  • Able to interpret design drawings (including GD&T) and product specifications.
  • Gage R&R experience a plus.
  • Experience with process validation, design verification/design validation.
  • Problem-solving/Troubleshooting experience.
  • Understanding of Lean Manufacturing tools, such as value stream mapping, 6S, Kazan, etc.
  • Strong interpersonal, organizational, and communication skills.
  • FDA and ISO 13485 knowledge.
  • Metrology, auditing, and data analysis experience.
  • Computer/data entry skills.
  • Written/report writing skills.
  • Experience training production associates, inspectors, or junior engineers.
  • Experience with industrial or manufacturing statistics.
Preferred Qualifications
  • MDD, MDR, CMDR, and JPAL knowledge.
  • Regulatory experience.
  • Experience with design verification/design validation.
  • Knowledge of EO and Gamma sterilization processes.
  • Engineering/design background.
Other Requirements
  • Ability to regularly walk, sit, or stand as needed.
  • Ability to occasionally bend and push/pull as needed.
  • Ability to pass pre-employment drug screen and background check.


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