Planet Pharma
Job Description
Position Responsibilities • Own all aspects of Software Design Quality for IVDR and RUO software, including risk management, design controls, and Design History File (DHF). • Provide Software Quality Engineering support for project planning, requirements/specification development, software verification, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors. • Own risk management activities, including the Risk Management File (RMF), risk management plan, hazard analysis, dFMEA, and risk management report. • Serve as the SME for Software Quality Engineering and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead the implementation of best practices for software quality processes. • Drive cross functional engagement with cross-functional stakeholders to optimize the success of development projects. • Support audits to ensure the quality and completeness of product DHFs • Conduct root cause investigations of product complaints and quality issues, initiate corrective actions, and monitor the implementation and effectiveness of corrective actions, when applicable. • Support other areas of the company's Quality Management System (QMS), when applicable.
Position Requirements • Bachelor's Degree or Master's Degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related engineering field. • 5+ years of experience in Software Quality Engineering experience, preferably within multiomics or bioinformatics. • Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. • Strong understanding of software developmental best practices for digital health software, Medical Device Data Systems, and cloud-based software/systems. • Organized self-starter, able to work in a fast-paced environment. • Exceptional analytical and problem-solving skills.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Position Responsibilities • Own all aspects of Software Design Quality for IVDR and RUO software, including risk management, design controls, and Design History File (DHF). • Provide Software Quality Engineering support for project planning, requirements/specification development, software verification, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors. • Own risk management activities, including the Risk Management File (RMF), risk management plan, hazard analysis, dFMEA, and risk management report. • Serve as the SME for Software Quality Engineering and collaborate with teams on code reviews, software security analysis, defect and vulnerability triage, creation and maintenance of sBOMs, etc., and lead the implementation of best practices for software quality processes. • Drive cross functional engagement with cross-functional stakeholders to optimize the success of development projects. • Support audits to ensure the quality and completeness of product DHFs • Conduct root cause investigations of product complaints and quality issues, initiate corrective actions, and monitor the implementation and effectiveness of corrective actions, when applicable. • Support other areas of the company's Quality Management System (QMS), when applicable.
Position Requirements • Bachelor's Degree or Master's Degree in Engineering, Bioengineering, Bioinformatics, Computer Science, or related engineering field. • 5+ years of experience in Software Quality Engineering experience, preferably within multiomics or bioinformatics. • Strong understanding of international medical device/IVDR regulations and standards, including 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971. • Strong understanding of software developmental best practices for digital health software, Medical Device Data Systems, and cloud-based software/systems. • Organized self-starter, able to work in a fast-paced environment. • Exceptional analytical and problem-solving skills.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.