Siemens Principal Software Design Quality Assurance Engineer in Norwood, Massachusetts
The Principal Software Design Quality Engineer will participate in the governance, and execution of the Quality Management sub-system element of Product Realization. Specifically, the person will be required to interact and collaborate with cross functional teams to promote and drive Quality Systems compliance regarding product design and development activities. Additionally, this role will lead specific quality improvement projects as required to support QT and other business initiatives including, but not limited to audits (internal / external), supplier quality, CAPA, and training. The individual filling this role is expected to apply advanced problem-solving techniques and interpersonal skills and be able to influence and drive results.
Major Job Responsibilities
Participateas a core team member on various design and development project activities;
Providestrategic oversight on design and development projects in specific regard to softwaredesign verification, design validation, and design change requirements;
Provideassistance to the engineering partners in the development of software designverification and validation testing requirements including protocoldevelopment, test case development, URS (User Requirements Specifications), SRS(System Requirements Specifications, CRS (Computer RequirementsSpecifications)…etc., acceptance criteria, and statistical plans / techniques;
Supportthe development, monitoring and reporting of Quality Systems key performanceindicators (KPIs), which will include assisting in the development of QualityGoals & Objectives across POC.
Support internal and external audit needs while serving as thesubject matter expert for Software Design Quality Assurance
Required Knowledge/Skills, Education,and Experience
10-15 years of experience in a Software Quality Engineeringor similar role within an FDA regulated industry preferably medical device anddiagnostics that includes experience with CAPA and auditing processes. ASQcertifications such as CQA, CRE, Six Sigma, CQE, CQT or equivalent are highly desirable.
Prefer candidates versed AGILE and GAMP5 or similar SoftwareValidation regulatory systems, e.g., CMMI
Job Family Responsibilities:
Analyze complex production and quality trend data to identify and solve problems. Designs and develops systems for recording, evaluating, and reporting quality data. Perform economic implication analyses, prepares reports of findings and carries out complicated implementation and training assignments. Conducts complex audits and/or surveys to determine acceptability of quality controls
Typically BS degree in a related discipline or equivalent combination of education and experience. Prefer discipline in Computer Science, Software Engineering, Biochemistry or Chemistry or other technical / engineering field. Prefer candidates that possess internal auditor certification (CQA) from ASQ or equivalent training in IVD / biomedical industry.
Knowledge and Experience:
Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.
Travel : <10%
Direction of Others: N/A
Key Working Relationships: Primarily intra-organizational contacts and external contacts.
Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity. Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.
(Note: Accommodations may be requested for certain medical or religious reasons)
Organization: Siemens Healthineers
Company: Siemens Healthcare Diagnostics Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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