Talent.com
NPA WorldWide
Sr SW Quality Assurance EngineerNPA WorldWide • Minneapolis, Minnesota, USA
Sr SW Quality Assurance Engineer

Sr SW Quality Assurance Engineer

NPA WorldWide • Minneapolis, Minnesota, USA
30+ days ago
Job type
  • Full-time
  • Permanent
Job description
Job description: Sr SW Quality Assurance Engineer, medical devices, remote This role both actively participates in the development of product and non-product (e.g., automated manufacturing test systems) software and firmware by serving as a core team member. Job Functions Serves as a core team member on software/firmware product development teams by providing technical leadership and direction. Responsible for the risk management file, compliance with design control regulations, development of design requirements, architecture specifications, and design verification/validation (including unit and integration testing). Chair the change control board within projects for change requests and defects identified during the course of development. Provide valuable technical feedback in code reviews. Lead (technical expert) and oversee/approve investigations of software/firmware related complaints, defects identified during development, or from manufacturing nonconformities, audit responses and CAPAs to identify root cause and corrective actions in a timely manner. Generates, maintains and updates risk management documentation throughout the life cycle of a product. Ensures compliance with software / firmware development and non-product software validation procedures. Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert. Knowledge, Skills and Abilities Required Experience with developing software or firmware in the medical device industry including demonstrated proficiency in meeting the requirements of IEC 62304. Develop and maintain strong, positive business relationships with key internal customers such as R&D, Clinical, Regulatory Affairs, and Operations to fulfill design development activities, support audits / inspections, and develop and implement plans that will ensure company compliance with regulatory requirements. Collaborate with other areas within Quality to achieve quality objectives. Exhibit strong leadership skills showing ability to influence both peers and other team members. Exhibit Excellent written and verbal communication skills. Demonstrate an ability to prioritize and plan activities. Possesses in depth knowledge of pertinent regulations (e.g. ISO 13485, 21 CFR Part 820, etc.) to assure the documentation of all company-wide functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements. This is not a sw test engineer role. Qualifications: Education BS in Computer Engineering, Computer Science, Electrical Engineering (with education/experience in software development) preferred, or other related degree. Advanced degree or professional certifications are valued. Experience with implantable medical devices is a major plus. Requirements 5+ years of experience Sustained record of performance during tenure in previous position. Has full accountability for representing Quality Engineering on project teams. Ability to present procedural requirements and design deliverables clearly during audits and regulatory inspections. Why is This a Great Opportunity: Work on novel neuromodulation devices for the treating of epilepsy and sleep apnea. This is a full remote role. *Salary Type *: Annual Salary *Salary Min *: $ 110 *Salary Max *: $ 150 *Currency Type *: USD
Create a job alert for this search

Sr SW Quality Assurance Engineer • Minneapolis, Minnesota, USA

Similar jobs

Sr Supplier Quality Engineer - AERO Manufacturing / REMOTE / Midwest Region

HoneywellMinneapolis, MN, United States
Remote
Permanent

Location :Remote-based with regular travel to supplier sites (local and domestic)The future is what you make it.We are looking for an experienced Sr.Advanced Supplier Quality Engineer to take owner... Show more

 • Promoted

Quality Engineer

Illinois Tool Works, Inc.Eden Prairie, MN, United States
Full-time

A thriving environment for learning, innovation and growth.Why do so many people join MTS Systems Corporation and stay for a career? Because this is a place where you get to apply your creativity, ... Show more

 • Promoted

Sr Quality Inspection Technician

Resolution MedicalMinneapolis, MN, United States
Full-time

Job TypeFull-timeDescriptionJob SummaryThe Sr.Quality Inspection Technician performs basic audit, inspection, test, and measurement duties on standard products and processes to ensure conformance t... Show more

 • Promoted

Senior Director- Quality Engineering

Daikin AppliedMinneapolis, MN, United States
Full-time

Join the world's largest HVAC company, named by Forbes as one of America's Best-In-State Employers 2025!Sr.Director Quality Engineering - Plymouth, MN - HybridMake your mark at the world's largest ... Show more

 • Promoted

Quality Tech

Advance - Global Australian ProfessionalsMinneapolis, MN, United States
Full-time

Job DescriptionAdvance Services has an exciting new opening for a Quality Tech in Fridley, MN!Responsibilities:Must be able to assist in Set-Up, in process, and final inspectionVisually inspect mac... Show more

 • Promoted

Sr. Plant Quality Engineer

Trane TechnologiesMinneapolis, Minnesota, United States of America
Full-time

Be a part of our mission! As a world leader in creating comfortable, sustainable, and efficient climate solutions for buildings, homes and transportation, it's our responsibility to put the planet ... Show more

 • Promoted

Quality Engineer (ERP Automation) Manager

PwCMinneapolis, MN, United States
Full-time

Industry/Sector Not Applicable Specialism Product Innovation Management Level Manager Job Description & Summary At PwC, our people in software and product innovation focus on developing cutt... Show more

 • Promoted

Sr Medical Device Quality Engineer

Primary Talent PartnersMinneapolis, MN, United States
Temporary

Primary Talent Partners has a new contract opening for a Sr Quality Engineer with our medical device client in Brooklyn Park, MN.This is a 12-month contract with a potential for extension.W2 contra... Show more

 • Promoted

Quality Assurance Manager - Laboratory

RMB Environmental Laboratories INCBurnsville, MN, United States
Full-time

Position Title:Quality Assurance ManagerCompany Overview: RMB Environmental Laboratories, Inc.Environmental Laboratories accredited by The NELAC Institute (TNI), specializing in comprehensive envir... Show more

 • Promoted

AVP, AI Quality & Reliability Engineering

VizientMinneapolis, MN, United States
Full-time

Vizient AI Quality Engineering Leadership.When you're the best, we're the best.We instill an environment where employees feel engaged, satisfied and able to contribute their unique skills and talen... Show more

 • Promoted

Quality/Quality Engineering Manager

CarecubesMinneapolis, MN, United States
Full-time

Quality/Quality Engineering Manager.OPERATIONS MINNEAPOLIS OR SAN FRANCISCO PREFERRED.CareCubes is an early-stage start-up company creating the future in negative pressure isolation units.We are hi... Show more

 • Promoted

Senior Manufacturing Quality Engineer

4C Medical Technologies IncOsseo, MN, United States
Full-time

Job TypeFull-timeDescriptionWe are seeking a detail-oriented and collaborative Manufacturing Quality Engineer to support the design, development, and commercialization of transcatheter mitral heart... Show more

 • Promoted

Director, Inspection Product Quality

OntoMinneapolis, MN, United States
Full-time +1

Onto Innovation is a leader in process control, combining global scale with an expanded portfolio of leading-edge technologies that include: 3D metrology spanning the chip from nanometer-scale tran... Show more

 • Promoted

Quality Auditor I (Production & Finished Product Inspector)- 2nd shift

EssilorLuxotticaMinneapolis, MN, United States
Full-time

Requisition ID:920076 Store #:WM0137 Optical Direct Edge & Mount BPARKPosition:Full-TimeTotal Rewards:Benefits/Incentive InformationSince 1915, Walman Optical has served thousands of independen... Show more

 • Promoted

Senior Manufacturing Quality Engineer

Custom SearchOsseo, MN, United States
Full-time

Our small medical device client is adding a Senior Manufacturing Quality Engineer to join their growing team.This is a critical role focused on leading our validation and verification efforts as th... Show more

 • Promoted

Sr Controls Engineer

Barry-WehmillerMinnetonka, MN, United States
Full-time

About Us: BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals ... Show more

 • Promoted

Global Quality Sr. Consultant-A&D

CelesticaMaple Grove, MN, United States
Full-time

Provides Global Quality leadership to the organization in an expanded manner, administering Quality Management System and associated quality protocols, along with supporting the operation teams tow... Show more

 • Promoted

Sr. Supplier Quality Engineer

Cirtec Medical Corp.Brooklyn Park, MN, US
$115,000.00 yearly
Full-time

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices.We specialize in providing comprehensive solutions for Class II and III devices, from desig... Show more

Supplier Quality Engineering Manager

Spectrum Safety SolutionsMinneapolis, MN, United States
Full-time

Supplier Quality Engineering Manager.Det-Tronics is seeking an experienced, process-driven Supplier Quality Engineering (SQE) Manager to own and lead the supplier quality management system and SQE ... Show more

 • Promoted

Manager, Quality Assurance

Geronimo PowerMinneapolis, MN, United States
Full-time

The Manager, Quality Assurance provides support for projects in development, construction, and operation by creating and managing a Quality Assurance program.This role ensures effective implementat... Show more