Engineer II Quality Assurance
Description
Description:
The Quality Assurance Engineer II is an experienced, self-sufficient representative that primarily works with a cross-functional team, such as Manufacturing, R&D, Regulatory, Quality Engineering, etc. In this position, your primary mission is to play a pivotal role in upholding the efficiency of the Quality Assurance department and ensuring unwavering compliance with our Quality Management System. This encompasses strict adherence to a comprehensive set of regulatory standards, including FDA GMP, ISO 13485, and MDSAP, among others.
The Quality Assurance Engineer also works independently to support efficient operations of the Quality Assurance department and compliance of the Quality Management system to ensure the quality of products and processes.
This role is central to safeguarding the quality of our products and processes. By adhering to these standards, you help to minimize the risk of defects and enhance the quality and safety of our products. Your dedication is essential to ensure that we not only meet but consistently exceed the quality expectations of our customers.
Beyond quality, your efforts contribute to the organization's compliance with an array of other pertinent regulatory requirements that pertain to our industry and the markets we serve. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access.
Responsibilities:
- Escalate issues to QA and/or Engineering Management if quality issues arise.
- Resolve quality related issues between the QA department and other departments.
- Coordinate with engineers, technicians, and production or other department heads to ensure quality standards are maintained.
- Ensure containment (identification, segregation, and reconciliation) of non-conforming product has been performed.
- Participate in cross-functional team to investigate quality issues/problems, perform risk assessments, historical record review and disposition and correction/corrective action strategy for non-conformances.
- Monitor and trend quality data to identify potential quality issues. Provide trended quality data to Management.
- Interpret and utilize Risk Management Files (Failure Modes and Effects Analysis).
- Ensure compliance to the Quality Management System and may own corrective actions (CAPA).
- Apply statistical methods to define sampling plans for Verification of Effectiveness.
- Evaluate required changes to electronic Quality Management systems for continued compliance to external standards and regulations. Assist in the implementation of new Quality modules in the electronic Quality Management system.
- Collaborate with other members of the QA team to achieve departmental/company goals.
- Support audit activities including supporting external audits and addressing audit findings.
- Perform other duties assigned as needed
Qualifications:
- Detail-oriented and organized.
- Excellent written and verbal communication skills, with the ability to interact effectively with internal and external stakeholders in both Spanish and English
- A keen eye for detail to ensure accuracy in documentation and compliance with regulations.
- Ability to work effectively within a team, collaborating with various departments and personnel to achieve common goals.
- Able to prioritize and efficiently complete tasks with consistency and accuracy with minimal supervision.
- Ability to analyze complex data, identify trends, and draw insights that inform strategic decisions.
- Proficient in critical thinking, problem-solving and analytical skills.
- Computer skills including Word, Excel and Internet Experience.
- Bachelor’s degree in Engineering or related technical field.
- Minimum 3 years of Quality Assurance experience.
- General knowledge of 21 CFR 820, ISO 13485 and MDSAP
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.