Quality Systems Engineer I/II Menlo Park, California, United States

Job Title: Quality Systems Engineer I/II

Location (on-site): Menlo Park

Department: Quality

Reports To: VP of Quality

COMPANY SUMMARY: Our ambitions are big at Jupiter. With a vision that spans the breadth of all cardiovascular disease, we are reinventing medicine with the endoportal procedure to bring the stability, control, and precision of direct surgical access to catheter-based interventions for the first time ever. By addressing loss of stability and control within the anatomy that has constrained percutaneous procedures for decades, we strive to usher in a new era for endovascular medicine so that patients can live longer, fuller lives. Jupiter Endovascular is a medical device start-up located in the San Francisco Bay Area and led by a team of successful medical device entrepreneurs. Our culture is built on innovation, teamwork, and speed. We have raised capital from a diversified investor base including venture capital, private equity, corporate strategic investors, and clinician angel investors.

Summary/Objective: Responsible for ensuring high quality products and compliant quality management system processes to support clinical and commercial use of Company products.

Essential Duties and Responsibilities

• Performs activities in quality systems pertaining to document control, design control, risk management, personnel training, quality audits, supplier management, product inspection/testing, nonconforming part control, product complaints, corrective/preventive actions, equipment calibration/maintenance, environmental monitoring, and product sterilization.
• Supports Document Change Order (DCO) process by ensuring timely DCO review, approval, incorporation, checking, and release.
• Participates in product life-cycle risk management process with focus on design, process, inspection and labeling controls.
• Provides technical support and leadership of quality deliverables in all product development phases.
• Develops and implements statistically valid sampling plans, designed experiments, and trend analysis in support of products and service improvements.
• Supports internal and external quality audits to ensure quality system compliance and effectiveness.
• Prepares quality system data for Management Review meetings.
• Coordinates supplier corrective actions as appropriate to ensure that quality requirements are met.
• Establishes quality inspection procedures. Ensures that appropriate inspection and test equipment is obtained and properly used for inspections and tests.
• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials.
• Initiates, performs, and documents product complaint investigations. Supports regulatory agency reporting as assigned.
• Assists in Corrective and Preventive Action (CAPA) process to ensure on-time completion of required activities.
• Perform lot history record and sterilization results review for product release.
• Ensures compliance with applicable state, federal, and international regulations and standards.

General Duties and Responsibilities

• Maintains quality system procedures related to areas of responsibility.
• Trains other Company personnel concerning areas of responsibility.
• Communicates information related to quality management system effectiveness.
• Manages electronic files in a secure manner to prevent unauthorized changes.
• Maintains various lists, logs and tracking systems related to documents and records.
• Works in accordance with quality system procedures.

Required Education and Experience

• BS in Engineering or Scientific discipline required.
• 3-5 years of medical devices quality assurance/engineering experience.
• Proficient with word processing, spreadsheet, presentation and document management software.
• Experience required in design, maintenance of quality management systems for medical device development, manufacturing, distribution, and post market surveillance.
• Experience required with international medical device regulations and standards.
• Experience required with application of statistical techniques for manufacturing and quality systems.
• Experience required with interpreting engineering drawings/specifications and establishing inspection sampling plans.

Languages: Full professional proficiency in English is minimum requirement.

Preferred Experience and Qualifications

• Willingness to work hard with a driven outlook and strong desire to succeed as an individual and in team roles.
• Ability to work well under pressure and to meet multiple and occasional competing deadlines while maintaining a cooperative working relationship with other people.
• Ability to work in a highly detailed environment where mental focus and accuracy of work output is essential.
• Good organizational and oral and written communication skills, including ability to represent the Company to both internal and external audiences.
• Experience using internet cloud storage services.
• Experience using statistical software such as Minitab.
• Experience using test and measurement equipment including microscopes.
• Good hand/eye coordination, manual dexterity, color vision, and visual acuity (corrected if necessary).

Work Environment and Personal Protective Equipment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, and scanners. Personal Protective Equipment may be required for assigned work.

The starting base pay for this role is between $90k-$125k depending on experience. The actual base pay is dependent upon many factors, such as: education, training, transferable skills, work experience, and business needs. The base pay range is subject to change and may be modified in the future. This role may also be eligible for equity, benefits and 401(K) with matching.

Jupiter Endovascular provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.