Principal Quality Engineer

Company Overview
Outset is a pioneering medical technology company that puts the patient before the machine. Our human-centered model is designed to dramatically improve not only the care experience – for patients, families, providers and physicians alike – but also cost-efficiency of dialysis delivery. We believe in introducing technology innovation in order to drive service model innovation. And in doing so, we intend to profoundly and permanently impact what, where and who can dialyze.

Position Overview
The Principal Quality Engineer is responsible for developing and maintaining quality engineering methodologies and providing quality engineering support within new product development, manufacturing, or system/services support.

Essential Job Functions
• Reviews and participates in the update/creation of design FMEA’s, process FMEA’s, application FMEA’s, and risk benefit analysis for medical devices.
• Develops and prepares monthly quality trend analysis and reports.
• Determines when process stability and capability studies should be performed on existing processes. Reviews and analyzes results, while recommending changes to processes based upon findings and perform follow ups to verify effectiveness.
• Analyzes and performs failure analysis to support complaint investigations.
• Ensures that development activities follow design control requirements and products are tested per applicable standards.
• Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products.
• Participates in or leads teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member).
• Manages the calibration process.
• Core Team Member in Supplier Qualification and Maintenance process.
• Leads or participates in supplier audits.
• Leads the investigation, resolution and prevention of product and process nonconformance.
• Leads and implements various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Leads, coaches, and mentors non-exempt and entry level exempt personnel.
• Leads in the implementation of assurances, process controls, and CAPA systems.

Requirements/Qualifications:
• BS degree in engineering or technical field or equivalent experience; M.S. or PhD preferred.
• 7+ years of related experience.
• Manufacturing experience with medical devices is preferred.
• Demonstrated supervisory experience preferred.
• Engineering experience and demonstrated use of quality tools/methodologies.
• Detailed knowledge of medical device regulation and standards such as 21 CFR 820, GMP, EN ISO 13485, and ISO 14971.
• Solid communication and interpersonal skills.
• Strong project management and leadership skills, including the demonstrated ability to lead multi- departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.
• Prior medical device experience is preferred.
• Experienced in implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
• ASQ CQE or other certifications are preferred.