Randstad Senior Quality Engineer in Saint Louis, Missouri
Senior Quality Engineer
location:Saint Louis, MO
salary:$80,000 - $100,000 per year
date posted:Monday, May 13, 2019
Senior Quality Engineer
This is an exciting opportunity to join as a Quality Engineer in a medical device or pharma environment.
Looking for 5 years of Quality experience in a regulatory environment in a pharmaceutical or medical device company with FDA regulation and ISO experience
Experience on the devices themselves, and what's embedded in the device software.
location: Saint Louis, Missouri
job type: Permanent
salary: $80,000 - 100,000 per year
work hours: 9am to 5pm
Responsible to assure Quality and Compliance, and provide overall Quality guidance during software development and validation of embedded software in the surgical devices
Reviews and approves design and development planning documents and design change requests.
Reviews and approves product requirements, system requirements, software requirements specifications, software architecture specifications, software detailed designs requirements using requirements traceability analysis.
Reviews and approves Risk Management documentation.
Review and approve Software Integration Test, Software System Test and Design Validation Test protocols and reports.
Reviews and approvals ensure document deliverables with internal directives and SOPs and external industry standards and regulations.
Influence the requirements definition and software design to maximize quality of requirements.
Act as a process advisor to coordinate risk controls, specification traces, verification / validation testing, and anomalies tracking for resolution.
Work closely with the software development team in risk management.
Collaborate with other engineering disciplines, such as mechanical, electrical, and industrial design, to ensure that embedded software will accomplish design goals for a particular product.
Help guide R&D teams through Quality Management System to ensure software is developed in compliance to internal procedures, as well as the requirements of FDA, ISO, and other regulatory bodies.
Scope of the referenced key activities and responsibilities is primarily project-based, with extended scope for the development and/or update of procedures, work instructions, forms and templates required to execute this role.
- Bachelor Degree in Computer Science, Computer Engineering, or Software Engineering
skills: Top Skills
Thorough understanding of software quality assurance principles, practices and metrics, as well as best practices that foster high quality software.
Deep knowledge of embedded software testing
Excellent analytical, problem solving, organizational, and communication skills
5+ years in the field of software with at least 3 years of hands on experience in a technical Quality role supporting a product design function in the development, testing, validation, approval and release of embedded software in medical devices hardware.
Demonstrated work experience in a role within a Design Quality function with responsibility of Quality Assurance and Compliance for device software in FDA regulated products.
Proven record supporting the development and execution of software test protocols for complex medical devices.
Familiarity with EN 62304, EN ISO 14971, EN 62366, FDA regulations and international standards applicable to medical device design, development, verification and validation.
Working knowledge of FDA guidance for Medical Device Software Validation
Former experience as a software developer using C, C++, C#, APIs, or equivalent.
Worked with teams on 510(k) submissions and/or PMAS.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.