Job summary
Job post source
This job is directly from cGxPServe
Job overview
The Medical Device Engineer at cGxPServe is responsible for developing and maintaining software quality assurance processes for non-product software in medical device development, ensuring regulatory compliance and quality standards.
Responsibilities and impact
The role involves implementing quality assurance processes, supporting regulatory audits, validating computerized systems, creating and reviewing validation deliverables, conducting periodic reviews, system retirement, collaborating with software and IT teams, and driving continuous improvement in software development processes.
Experience and skills
Candidates need a bachelor's degree in engineering or related fields, 4-5 years in software quality assurance or validation preferably in medical devices, strong knowledge of FDA, ISO, IEC standards, experience with non-product software validation, GxP and 21 CFR Part 11 assessments, and familiarity with tools like JIRA and JAMA is a plus.
Unique job features
This role focuses specifically on non-product software quality assurance within medical device development, emphasizing regulatory compliance and validation deliverables unique to this sector.
Company overview
cGxPServe operates in the engineering and information technology sectors, specializing in research services with a focus on manufacturing, process control systems, and clinical data management. The company provides expertise in areas such as supplier quality, regulatory affairs, clinical project management, and data programming, serving clients in highly regulated industries, including medical devices and pharmaceuticals, as indicated by references to ISO 13485 and 21 CFR 820 compliance. cGxPServe generates revenue through professional services and staffing solutions, supporting roles like manufacturing engineers, clinical data managers, and regulatory specialists. With locations in California and North Carolina, the company is positioned to address complex compliance and operational needs for clients. Its history and growth reflect a commitment to supporting quality and regulatory standards in life sciences and advanced manufacturing.
How to land this job
Position your resume to highlight your expertise in software quality assurance and validation specifically for non-product software in the medical device industry, emphasizing your familiarity with FDA, ISO 13485, and IEC 62304 standards.
Emphasize your experience with Computer System Validation (CSV), GxP, 21 CFR Part 11 applicability assessments, and your ability to create and review validation deliverables such as Requirement Specifications, Qualification Protocols, and Traceability Matrices.
Apply to the Medical Device Engineer role through multiple platforms including cGxPServe's corporate career site, LinkedIn, and other reputable job boards to maximize your visibility.
Connect with current employees in the quality assurance or regulatory compliance divisions at cGxPServe on LinkedIn; start conversations by mentioning your interest in their work on software validation or asking about best practices they follow for compliance.
Optimize your resume for ATS by incorporating key phrases from the job description like 'Computer System Validation,' '21 CFR Part 11,' 'GxP,' 'FDA,' 'ISO 13485,' and 'IEC 62304' to ensure your resume passes automated screenings.
Utilize Jennie Johnson's Power Apply feature to automate tailored resume creation, multi-channel job applications, and strategic LinkedIn networking, allowing you to focus your time on preparing for interviews and skill enhancement.
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