Quality Assurance Engineer
1 week ago
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.
- 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.
- MDD, MDR, CMDR, and JPAL knowledge.
- Regulatory experience.
- Experience with design verification/design validation.
- Knowledge of EO and Gamma sterilization processes.
- Engineering/design background.
- 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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