Senior Quality Engineer

Senior Quality Engineer

Join us for an enriching journey with Outset, a trailblazing medical device company that is revolutionizing the field of dialysis. Our focus is to create one high performing team, obsessed with progress, in an atmosphere that is brimming with transformative opportunities. The heart of our mission is pioneering a groundbreaking technology that redefines the landscape of dialysis, streamlining complexity and cost, because patients deserve "better" now, not some day.

At Outset we're revolutionizing an industry and changing lives. We're impacting what the future of dialysis looks like by creating a first-of-its-kind technology in order to reduce the cost and complexity of dialysis. FDA cleared for use across care settings, from the hospital to the clinic to the home, the Tablo® Hemodialysis System harnesses modern technology for a new holistic approach to dialysis care. We're giving providers time back to focus on patient care. And we're giving patients the power to take control of their life and get back to enjoying the things they love.

Position Overview:

The Quality Engineer will focus on development of Process Validation strategies, non-conformances, MRB, CAPA's, tracking and reporting on monthly basis and compiling and presenting data for management review, execution, and approvals of change orders.

Essential Job Functions and Responsibilities

Core Job:

• Manufacturing process sustaining (Cleanroom environment).
• Sterilization concepts and product release.
• Contractor’s management, such as external laboratories and sterilization sites.
• Quality Inspectors management.

Supporting:

• NPI’s activities from SJ Facility to MX facility by developing and executing the transfer validation strategy. (IQ, OQ or PQ)
• Change orders for process improvements and determines when process stability and capability studies should be performed on existing processes.
• Analyzes and performs failure analysis to non-conforming products.
• Leads in the implementation of assurances, process controls, nonconformances and CAPA.
• Reviews and participates in the update/creation process FMEA’s, application FMEA’s, and risk benefit analysis for medical devices.
• Develops and prepares monthly quality trend analysis and reports.

Interpersonal skills:

• Leads, coaches, and mentors non-exempt and entry level exempt personnel.
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.

Support additional activities, as assigned.

Required Qualifications

• Bachelor’s degree in engineering or technical field or equivalent experience is required.
• Minimum of 5+ years of experience.
• Knowledge of medical device regulations and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
• Able to read and understand technical data.
• Competent using Microsoft Office suites.
• Strong written and verbal communication in English.

Desired Qualifications

• Good analytical, communication (both verbal and written) and presentation skills.
• Statistical analysis software a plus.
• Effective analytical, technical, and problem-solving skills.
• Ability to multi-task and manage multiple assignments in a timely manner.
• Strong analytical skills.
• Quality engineering certification, Lean Six Sigma certification.

Important Notice: We have been made aware of fraudulent activities where individuals are impersonating our company and offering fake job opportunities. Please note, Outset Medical will never request payment or gift cards during the hiring process, nor will we ask you to purchase your own equipment. Anyone reaching out to you with an email address ending in @outsetmedical.cc, is not a legitimate Outset representative. For legitimate opportunities, always apply directly through our official careers page. If you are unsure about the authenticity of a communication, contact us immediately at peopleops@outsetmedical.com.

Equal Employment Opportunity Statement: Outset Medical is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind on the basis of race, color, national origin, religion, gender, gender identity, sexual orientation, disability, genetic information, pregnancy, age, or any other protected status set forth in federal, state, or local laws. This policy applies to all employment practices within our organization.