Similar posts
Senior Software Quality Assurance Engineer
- Permanent
- Manufacturing, Field, Project Engineering
- United States
This vacancy has now expired. Please see similar roles below...
Senior Software Quality Assurance Engineer - Permanent - Burlington, MA
Proclinical is on the lookout for a skilled Senior Software Quality Assurance Engineer. This is a permanent role located in Burlington, MA.
Primary Responsibilities:
The successful candidate will play a crucial role in product software development and validation activities within a medical device organization. Please note that eligibility to work in the US is a requirement for this role.
Skills & Requirements:
- Experience with New Product Development (NPD) of a software medical device, including completion of software validation for a regulatory submission.
- Knowledge of current regulatory industry standard requirements for administration of design control and validation elements of the Quality System in alignment with FDA 21 CFR Part 11 & Part 820, ISO 13485:2016, and IEC 62304:2006.
- Proven experience creating Software Development Life Cycle (SDLC) procedures.
- Ability to write and maintain requirements throughout a software development project.
- Experience with SDLC tool selection and validation.
- Familiarity with complex UI development and validation.
- Effective verbal and written communication skills.
- Strong organizational, problem-solving, and analytical skills.
The Senior Software Engineer will:
- Collaborate with the design team in software development activities, including planning, requirement development, software design output, change/configuration management, risk management, design reviews, and releases.
- Review and approve software product documentation.
- Oversee software validation testing activities and related documentation.
- Design test strategies and write test plans and cases.
- Validate automated tests and development/production tools.
- Log and verify bugs, and assist in root cause investigation and corrective action activities.
If you are having difficulty in applying or if you have any questions, please contact Victoria Kroon at +(1) 929-387-4315 or v.kroon@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Related jobs
Swiss Franc120000 - Swiss Franc125000 per annum
Oensingen, Schweiz
Proclinical is working alongside a biotechnology company to recruit for a Senior QA and Systems Engineer in Software. This is a permanent position based in Oensingen, Switzerland.
Highly Competitive
Chester, England
Proclinical are working alongside a biotechnology company to recruit for a Project Engineer. This is a permanent position based in Chester, United Kingdom.
US$30 - US$35 per hour
Gaithersburg, USA
Proclinical is collaborating with a pharmaceutical company to recruit for a Process Engineer. This is a temporary contract position based in Gaithersburg, Maryland.
€105000 - €110000 per annum
Oberkochen (73447), Deutschland
Proclinical sucht einen Lead Developer Software C# / .Net - Semiconductor Manufacturing Technology (m/w/d) für eine Festanstellung in Oberkochen, Deutschland.
Highly Competitive
Stein, Switzerland
Proclinical are working with a biotechnology company to recruit for an experienced CQV Engineer. This is a temporary contract position based in Stein, Switzerland.