Senior Supplier Quality Engineer at Outset Medical

Tijuana, Baja California, Mexico

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

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
Strong verbal and written communication skills in English
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

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
Maintain good communication and interpersonal skills, such as supplier relationships, internal collaboration, stakeholder management, problem solving, influencing, negotiation, and customer satisfaction
Oversee supplier performance and provide regular reports to management to ensure transparency and accountability
Contribute to the refinement of supplier control plans to drive ongoing quality improvement

Skills

Supplier Quality

Continuous Improvement

Supplier Performance Management

Analytical Skills

Problem Solving

Regulatory Compliance

Quality Control Plans

Supplier Collaboration

Outset Medical

Dialysis treatment solutions and training programs

About Outset Medical

Outset Medical focuses on improving dialysis treatment in the healthcare sector. Their main product, Tablo, is a system that simplifies the dialysis process by integrating with electronic medical record (EMR) platforms, allowing for better management of patient data with real-time updates and alerts. This helps streamline workflows from charting to billing. In addition to Tablo, Outset Medical provides educational programs and hands-on training for dialysis professionals, including a Vascular Access Program that enhances staff skills in cannulation and vascular access management. They also offer a Bridge Program to assist facilities transitioning to in-house dialysis services by providing experienced dialysis nurses for training and support. Outset Medical aims to enhance the quality of care for dialysis patients across various settings, including hospitals, outpatient clinics, and home care.

San Jose, CaliforniaHeadquarters

2010Year Founded

$542.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Medical, dental, & vision

Life Insurance/AD&D

FSA & HSA

401k

Parental leave

Pet insurance

Tuition reimbursement

PTO

Company events

Risks

Multiple class action lawsuits could lead to financial and reputational damage for Outset.

The shipment pause of TabloCart with Prefiltration may have disrupted supply chains.

Reliance on partnerships, like with U.S. Renal Care, poses risks if expectations aren't met.

Differentiation

Outset Medical's Tablo system integrates with EMR platforms for streamlined dialysis workflows.

The company offers a Vascular Access Program to enhance staff expertise in cannulation.

Outset Medical provides a Bridge Program for facilities transitioning to in-house dialysis services.

Upsides

Increased adoption of home dialysis solutions aligns with Outset's partnership with U.S. Renal Care.

The demand for portable dialysis machines supports the market potential for Outset's Tablo system.

Outset's FIPS 140-3 validation enhances cybersecurity, aligning with new medical device standards.

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