Senior Supplier 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 Senior Supplier Quality Engineer (SQE) plays a critical role in maintaining and continuously improving the quality of materials and components procured by the business. This position oversees supplier performance, provides regular reports to management to ensure transparency and accountability, and contributes to the refinement of supplier control plans to drive ongoing quality improvement.

By collaborating closely with suppliers, the Senior SQE develops and implements strategies to enhance product quality, process reliability, and overall supplier capability. Success in this role requires strong analytical and problem-solving skills, the ability to manage multiple priorities effectively, and a proactive approach to ensuring consistent compliance with company and regulatory standards.

Essential Job Functions and Responsibilities

· Driving continuous improvement initiatives with suppliers and internal teams.

· Conduct comprehensive audits and capability assessments of supplier facilities, processes, and quality systems.

· Analyzing supplier performance data to identify trends and areas for improvement.

· Follow up corrective actions, ensuring the implementation of corrective actions in response to quality issues, while also assessing the adequacy of root cause analysis tools employed to address reported issues.

· Support or execute change orders for process improvements and determine when process stability and capability studies should be performed on existing suppliers.

· Analyzes and conducts failure analysis on non-conforming products.

· Review and participate in the component qualifications (PPAP), MSA, and supplier control plans.

· Manage qualifications of changes, oversee the qualification process for changes initiated by suppliers and the company, and coordinate associated change control activities to ensure seamless integration and compliance with quality standards.

· Develops and prepares monthly suppliers quality trend analysis (Scorecards).

· Lead the supplier qualification and maintenance process, including audits, new supplier introduction.

· Good communication and interpersonal skills, such as supplier relationships, internal collaboration, stakeholder management, problem solving, influencing, negotiation, and customer satisfaction.

Required Qualifications

· Bachelor’s degree in quality, Mechanical, or Industrial Engineering, or related field.

· Minimum of 5+ years of supplier quality or working with supplier qualification projects.

· Experience in a medical device or other regulated industry is required. 

· Strong verbal and written communication skills in English are required.

· Comprehension 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 (drawings, GD&T, etc.).

· Effective analytical, technical, and problem-solving skills. Applies rigorous methodology to complex problems, including Six Sigma methodology.

· Deep knowledge of sampling plans and statistical techniques.

· Lead Auditor certification.

Desired Qualifications

· Certification in Quality elements such as Quality Engineering or Lean Six Sigma.

· Willing to work with people in an international environment.

· Flexibility to travel domestically and internationally for supplier visits and audits.

At Outset, we believe every person matters. Every Outsetter, every patient, every caregiver. Because we are here to create a revolution, and we believe in doing that by innovating everywhere with intelligent speed. Our team expects nothing less than our best display of strengths and skills, and we find joy in working together for a common goal. At Outset, we believe that curiosity, ingenuity and conviction in the power of technology will transform the lives of dialysis patients and providers. 

We are fueled by the opportunity to give people their lives back. And we believe that it begins with YOU, our future Outsetter. At Outset, we’ve designed a professional world that our employees are honored and impassioned to belong to, one that offers challenge, the ability to collaborate with great people, and opportunities to build skill and expertise in a fulfilling career. 

An opportunity at Outset Medical won’t just be about finding a job. Our culture revolves around the principles of moving farther, faster, together, so working here feels like a masterclass in peak performance, for individuals and teams. 

Privacy is important to us. Please review our Applicant Privacy 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.