Job Listing Description

Software Quality Engineer / Quality Management - Medical Device

Description:
Software Quality Engineer / Quality Management - Medical Device
Start: ASAP
Location: Work can be 100% remote
Project Type: Contract (W-2 Only)
Project Length: 6 months to start
Pay: $55.00 - $70.00 per hour +/- (depending on experience)

*This role can be 100% remote. If candidate is local to Indianola PA, would be hybrid.

DEPARTMENT/TEAM DESCRIPTION
Radiology Software Assurance & Operations Team

Primary Function:
• Software Quality Management of Radiology device products to meet FDA design controls and other regulatory bodies
• Software Quality Management of GxP relevant computer systems

POSITION SUMMARY
This position will be responsible to perform software quality management activities of medical devices (Class-2) to deliver a high-quality product that meets or exceeds customer expectations and meets FDA design controls and other regulatory bodies.

POSITION DUTIES & RESPONSIBILITIES
Activities
• Software Quality Management of Software in Medical Device (SiMD) of Class-2 and Class-1 medical devices, including Application software, Embedded software, Platform software, Operating system software
• Software Quality Management of Software as a Medical Device (SaMD) of Class-2 and Class-1 medical devices, including Application software, AI/ML software, Platform software including IaaS and PaaS, Cloud based software
• Responsible for ensuring development initiatives of Bayer Radiology medical devices complies and adheres to regulatory standards and guidance such as FDA Design Controls CFR 820.30, IEC 62304
- Software in a Medical Device, IEC 82304
- Software as a Medical Device, IEC 14971
- Risk Management, ISO 13485
- Quality Management Systems, 2017/745
- European Union Medical Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device: Clinical Evaluation
• Conducts evaluation of software engineering activities of medical device development including requirements, software risk analysis, design, development, documentation, integration, verification, validation and release to deliver medical devices that are safe, secure and effective
• Reviews all the deliverables of medical device software lifecycle and provide clear, concise, and timely feedback to stakeholders
• Responsible for ensuring computer system validation initiatives in Bayer Radiology organization complies and adheres to standards and guidance such as General Principles of Software Validation, Computer Software Assurance for Production and Quality System Software, FDA CFR Part 11 Compliance
• Provides guidance to cross functional teams to ensure software quality objectives are met for medical device software development
• Engaging in continuous improvement initiatives to establish Center of Excellence (CoE) in Software Assurance function such as Software Problem Resolution meetings and documentation, CAPA actions, Process and template updates and Audit support

REQUIREMENTS / PREFERENCES
Skill & Competency Requirements:
• Bachelors degree in Computer Engineering, Electronics, or Electrical Engineering
• Minimum of 7 years of relevant work experience in software engineering or quality engineering in medical device development
• Minimum of 2 years of relevant work experience in software quality management of Class 2 or Class 3 medical devices including Software in Medical Device (SiMD) or Software as Medical Device (SaMD)
• Minimum of 2 years or more of experience in interpreting industry standards for medical device development and updating processes and procedures
o Quality Management System - ISO 13485
o SiMD - IEC 62304
o SaMD - IEC 82304
o FDA 21 CFR 820.30
o 2017/745 - European Union Medical Device Regulation (EU MDR)
• Minimum of 2 years or more of experience in applying industry standards for medical device development as follows
o General Principles of Software Validation
o FDA CFR Part 11 Compliance
• Must be able to handle multiple tasks/projects and manage priorities accordingly.
• Technical writing ability - clear and concise writing easily understood by multiple audiences (auditors, peers, etc.)
• Ability to work in-office and remote

Preferences:
• Familiarity with AI/ML based medical device software quality management
• 2 or more years of relevant work experience in various phases of software development lifecycle including requirements, architecture, design, development, testing, release, deployment, post-launch support activities
• 2 or more years of programming experience in any of the following languages C, C#, Java, React JS, Angular
• Working knowledge of tools including JIRA, AWS, GitHub, Rational Quality Manager, DOORS Next Gen
• Working knowledge on OS such as Windows, Linux flavors
• Demonstrated ability working in a matrix/hybrid organization structure
• Ability to troubleshoot and make quick knowledge and experience-guided decisions
• Excellent written and oral communication
• Excellent people skills, ability to partner well, good team camaraderie
• Proficient with Microsoft Office tools especially MS Word, MS Excel, MS PowerPoint, MS Project, and other management tools

Pay Details: $55.00 to $70.00 PER HOUR

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.pdstech.com/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.

Job Number: US_EN_33_023028_2158651
Job Location: Indianola, PA
Rate: 55-70
Per Diem: --
Overtime: --
Duration: indef
Start Date: ASAP
Input Date: 09/11/2023
Last Updated: 09/24/2023

Firm Name: PDS TECH COMMERCIAL, INC
Attention:
Address: P O BOX 619820
City, State: DALLAS, TX 75261-9820
Phone: 214/647-9600
800 Phone: 800/270-4737
Email:
Website: Go To PDS Tech Commercial Website

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