Senior Software Quality Engineer
Arden Hills, MNFull-time$125–162K/yrSeen 1w agoSeen in employer's feed 6 days ago
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Job overview
Boston Scientific seeks a Senior Software Quality Engineer to provide independent review and guidance on software deliverables and lead software validation activities. The role guides project teams on validation processes, enterprise systems implementation, and regulatory compliance, and contributes to SOPs and work instructions. The position is based in Arden Hills, Minnesota, and may require travel or telecommuting.
Skills & qualifications
Skills
Qualifications
Benefits
Full job description
Job Duties
Boston Scientific Corporation seeks a Senior Software Quality Engineer at its Arden Hills, MN location.
DUTIES: Acts as an effective team member providing independent review and guidance on deliverables used to develop, implement and maintain IT/clinical/manufacturing/quality software. Act as a subject matter expert on software validation to guide/ coach/ train project teams on effective and efficient implementation of BSC software validation processes. Demonstrate mastery of the software validation processes at BSC (examples include GSM, Spreadsheet Validation). Work with management to understand priorities and plans/provides input to resource and time allocation accordingly. Play key role in providing full guidance and direction on acceptability of Software Quality and Validation deliverables. Lead, acknowledge, develop, communicate, and implement a validation strategy to ensure compliance. Guide implementation of enterprise systems solutions through planning, system integration, and verification and validation activities. Engage in continuous improvement activities while ensuring that Boston Scientifics’ software systems are defensible for regulatory requirements. Contribute to the development, review and / or approval of SOPs and supporting Work Instructions. May require travel/telecommute.
WORKSITE: 4100 Hamline Ave. N., Arden Hills, MN 55112
Minimum Education Required
REQUIREMENTS: Employer requires a Bachelor’s degree or foreign equivalent in Computer Science, Computer Engineering, Information Systems, or a related technical field.
Minimum Experience Required
REQUIREMENTS: Employer requires a Bachelor’s degree or foreign equivalent in Computer Science, Computer Engineering, Information Systems, or a related technical field plus 60 months in the job offered, Software Developer, Consultant, or related occupation. Experience must include: 1) Computer System Validation, 2) Quality assurance and Quality control, 3) Policy/Process Development, Risk Assessment, Auditing and Reporting, and CAPA Management, 4) Device Software Validation, 5) Agile Methodologies, 6) ISO Standards 13485 and 21 CFR Part 11, 7) Jira and Service Now tools experience, 8) Enterprise Application such as SAP S4 HANA experience, and 9) Software & Equipment Validation.
Shift
First (Day)
Number of Openings
1
Compensation
$124,883.00 - $161,500.00 / Annually
Postal Code
55112
Job Type
Full Time
Place of Work
On-site
Requisition ID
H4872-01133
Job Benefits
Boston Scientific offers medical & dental coverage, well-being support, & 401K plan (EOE).
Application Instructions
CONTACT: Susan Cardinal, Boston Scientific Corporation, [email protected]. Must include reference H4872-01133.
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