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React Health · 1 hour ago

Senior Manager, Quality Engineering

Bothell, WA

Full-time

Onsite

Senior Level

$150K/yr - $165K/yr

7+ years exp

React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment, dedicated to supporting patients, caregivers, physicians, and healthcare providers. The Senior Manager Quality Engineering provides resource to support New Product Development, Design Transfer, Manufacturing and Sustaining of commercialized product including Receiving Inspection.

Health CareManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Ability to review and approve changes to currently commercialized product w.r.t. the use, design and process risk management of the product

Manages Design Quality, Manufacturing Quality and Quality Control (Receiving Inspection) resources and processes

Applies statistics to make business decisions

Ability to conduct failure investigation and root cause analysis

Must be able to work in lower maturity processes using critical thought to provide pathways for business continuity and improve the systems

Ability to manage remote employees, effectively and efficiently

Coordinate and work closely with other engineering, logistics, financial, and program management disciplines to define system specifications and requirements

Attends and participates in departmental meetings

Attends seminars and training sessions necessary to maintain appropriate level of professional competence

Ensures all department compliance guidelines are met

Attends all meetings, in-services training, or continuing education as delegated by the supervisor

Provides customer focused interactions

Performs all duties necessary for the department as per department policies and procedures

Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department

Qualification

Medical Device Design ControlISO14971ISO13485IEC62304Design ValidationDesign VerificationProcess ValidationRisk ManagementControl PlansInspection SpecificationRoot Cause AnalysisProject ManagementCommunication SkillsAttention to Detail

Required

7+ years of experience or equivalent experience in Medical Device Design control and the application of ISO14971, 21CFR820, ISO13485, IEC62304, IEC 62366, IEC 60601

5+ years or equivalent experience as a people manager

Experience with new design, design transfer, manufacturing and sustaining of electro-mechanical and software driven devices

Experience with Test Method Validation, Design Validation, Design Verification and Process Validation

Experience with Risk Management file creation (use, design and process) and maintenance

Experience with Control Plans

Experience with Inspection Specification creation and Receiving Inspection execution

Bachelor's in Engineering

Preferred

Master's in Engineering

Excellent attention to detail and project management skills

Excellent written/oral communication skills. Must be able to work effectively with diverse groups of people

Company

React Health

React Health provides medical devices for the treatment of sleep-disordered, breathing, and oxygen therapy.

Founded in 2010

Sarasota, Florida, USA

201-500 employees

https://www.reacthealth.com

H1B Sponsorship

React Health has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2024 (2)