Responsible for fulfilling the role of Obalon’s Quality expert; this is a hands-on position. Ensure the quality of the products produced at Obalon meet all customer expectations. Maintain the most recent interpretations of the quality system requirements and therefore ensure that documented practices meet the true interpretation of the quality management system standards.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Quality Engineer will:
Act as Complaint Lead: Maintain complaint log, handle returns, perform mechanical and functional testing and documents root cause investigations related to non-conformities, Complaints, Audits, CAPA, post market surveillance, and product support as required to determine deficiencies in product and manufacturing processes.
Manage at-risk patient tracking and follow up activities for patient-events that have or may lead to a complaint record.
Create, investigate, disposition, and close NCP’s (Non-Conforming Product).
Assist in the performance of equipment calibration.
Assist with Internal or Notified Body audits.
Develop monitoring systems by identifying critical process steps in processes and/or Quality Systems to capture quality metric data and execute / report trend analysis to lead process and compliance improvements.
Perform continuous improvement activities/projects to improve Product Quality, Compliance and the Quality System. Responsible for ensuring internal/external Quality Systems Requirements are adhered to throughout product and process lifecycles
Leads teams through risk- based approach for new and/or modified products and processes which includes risk assessment occurs in the appropriate phase of the project, authoring risk management plans and reports, facilitating risk assessment activities with no guidance required.
Manage CAPA’s including CAPA Requests, Investigations, CA/PA Action Plans, and Verification of Effectiveness (VoE).
Provides training to company as it relates to Quality Systems or processes.
Assist corporate management in implementing and maintaining a quality system that adheres to European, US, and other regulatory and Quality System requirements (ISO, CFR, MDD, etc.), by providing input regarding compliance of design control, risk management, adequacy of testing and processes and production control systems with applicable standards.
This position assumes and performs other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
The QE must be able to work in a fast-paced environment; must have the ability to work on multidisciplinary teams; have strong verbal and written communication skills; demonstrate problem-solving, organizational, troubleshooting, time management, and decision-making skills; be able to identify and address all complexities of compliance issues; be extremely detail oriented.
EDUCATION and/or EXPERIENCE
Bachelor's degree (B.S.) from four-year college or university in science or technical discipline or higher
The following is preferred but not required:
5 or more years Quality Engineering experience in Medical devices
Class III product experience a plus;
Experience in Global Quality Systems (i.e., ISO13485, QSRs, etc.) and Medical Device Regulations (CFR, MDD, SOR, etc.) as it relates to department and job duties described within this document.
CERTIFICATES, LICENSES, REGISTRATIONS
Certified Quality Engineer (CQE) is preferred but not required.
About Obalon Therapeutics
Obalon is an engineering-driven medical technology company with a singular focus on innovative, high-quality gastric balloon technology. Located in San Diego, California, the technical team at Obalon has a long history of working closely with leading clinicians to develop innovative medical products that revolutionize treatment of chronic disease.