Sr. Quality Engineer
Description
Description:
Play a pivotal role in upholding the efficiency of the Quality 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. Your 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. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access. The Senior Quality Engineer will work with Production and Engineering departments to manage and resolve non-conformities, validate processes, resolve customer issues, and continually improve the quality system. 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.
Play a pivotal role in upholding the efficiency of the Quality 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. Your 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. This regulatory adherence is pivotal in maintaining our reputation, fostering customer trust, and ensuring market access. The Senior Quality Engineer will work with Production and Engineering departments to manage and resolve non-conformities, validate processes, resolve customer issues, and continually improve the quality system. 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.
Responsibilities
- Escalate issues to functional Managers f quality issues arise.
- Resolve quality related issues between the Quality department and other departments.
- Coordinate with engineers, inspectors, 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 teams 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).
- Lead investigations of product quality and compliance issues related to NCRs and CAPAs including analyzing results and making recommendations.
- Recommend test methods and statistical process control (SPC) for achieving required level of product quality.
- 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.
- Develop statistical models to identify products or processes posing excessive failure risks.
- Assist in the implementation of new Quality modules in the electronic Quality Management system.
- Support process, product and/or equipment validation transfers, and design process activities (e.g., IQ, OQ, PQ, etc.)
- Collaborate with other members of the Quality team to achieve departmental/company goals.
- Review engineering change orders for impact on specifications, product quality, and compliance.
- Identify and implement any changes necessary to the quality systems and compliance procedures to ensure and maintain the continued suitability and effectiveness of the quality management system using the quality policy, quality objectives, audit results, analysis of data, risk management, etc.
- Support audit activities including supporting external and supplier audits and addressing audit findings.
- Perform other duties assigned as needed.
Qualification
- Detail-oriented and organized.
- Excellent written and verbal communication skills, with the ability to interact effectively with internal and external stakeholders.
- Fully bilingual (English – Spanish)
- 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.
- Ability to analyze complex data, identify trends, and draw insights that inform strategic decisions.
- Proficient in critical thinking, problem-solving and analytical skills.
- Thrive in a fast-paced and dynamic work environment.
- Computer skills including statistical/data analysis and report writing skills.
- Bachelor’s degree in engineering or technical field.
- Prior medical device manufacturing and quality engineering experience.
- Minimum 7 years of Quality Engineering experience.
- Thorough knowledge of advanced statistics and problem-solving techniques.
- General knowledge of 21 CFR 820 and ISO 13485.
- Certification in Six Sigma Black Belt or CQE - ASQ.
- General knowledge of MDSAP regulations.
- Advance statistics knowledge and applications to QA & manufacturing cases.
Inari Medical, Inc. advises applicants that employment is subject to completion of a successful background check.