Software Quality Engineer
$105000 to $115000 Per Year
Software Quality Engineer
Will support new product development activities, maintain compliance to company procedures and external standards, manage design history files, build verification and validation documentation, participate in risk analysis activities, collaborate on product development deliverable documentation, support creation of 510k packages, conduct failure\problem investigations, identify system issues, summarize findings and prepare reports for key quality metrics.
Responsibilities also include being the quality and compliance representative in the assigned teams.
- Responsible for being the prime quality representative for design control projects – new product development as well as sustaining efforts.
- Responsible for review and/or approval of design history file documentation in support of design controls.
- Manage all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory, compliance and product security support.
- Writes and/or leads risk management activities including risk management reports and risk analyses.
- Work closely with Program Managers to ensure design deliverables are met and can be released to limited commercial and/or general release.
- Works together with SW Quality Engineers to ensure effective verification of design specifications and/or requirements.
- Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
- Reviews and approves Change Orders and/or Electronic Release Authorizations for new releases or design improvements.
- Active participant in the development of product requirement, product system hazard analysis and design reviews.
- Work closely with Product Management to ensure effective validation of user needs.
- Ensure product technical files and Design History Files are complete and audit-able.
- Provide clarification and mentorship to teams on overall quality system with emphasis in design controls.
- Conducts audits as member of a quality system audit team (e.g. SME, etc.)
- Track record of root cause determination and effective corrective / preventive action implementation.
- Provides decisions, recommendations, and results to foster the achievement of goals critical to organizational objectives.
- Identifies areas requiring quality improvement and initiates and follows through plans of action (Quality Plans) vital for implementation.
- Quality lead in 510k or International submissions.
- Mentor to Quality Engineers on approach to design controls, agile design, risk management and product security. When applicable, have the ability to lead quality engineers.
- Bachelor's degree in engineering or life sciences.
- 10+ years related experience in design and development.
- ASQ certified (CQA, CQE, CSQE, CMQ) is a definite plus
- Must be able to apply quality principles (ISO 13485, IEC 62304, 21 CFR, etc.) to the R&D environment
- In-depth knowledge of software development life cycle and test methodology.
- Experience dealing with Software products highly desired
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