Senior Manager SW Quality
Senior Manager SW Quality
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Salary Not Disclosed
1 Vacancy
Job Description
Job Opportunity:
The Senior Manager focusing on Software Quality and associated design controls will have the opportunity to developand improvetechnology platforms that improve the lives of those suffering fromHeart Failure.
TheSeniorManager Software Design Control is responsible for managing a team of software quality engineerswho partner with the Software Development Groups and other functionsto solve problems and make sound design recommendations in accordance withCompany andregulatory requirements/guidance and standards. This position provides leadership and mentoring tosoftware qualityengineersandmust performas ahandson contributor as necessary.
Job Responsibilities:
- Provide guidance and strategic input to teams fordevelopment of medical product software(CloudBased Patient Care Networks Mobile and Embedded software) nonmedical softwareand nonproduct software.
- Lead improvement ofthe Heart Failure Divisions software design controlsto meet the needs of evolving technology and regulatory landscape around mobile software platforms and embedded software.
- Partner with the Product Security Group to continually improve cybersecurity and associated quality system processes
- Provide quality assurance oversight for software development lifecycle (SDLC) deliverables such as requirements risk management tracing software V&V regression defect management etc.
- Hire and retain a diverse highly qualified staff and provide ongoing performance feedback.
- Set goals which align tobusiness anddepartment plans and manage the of goals through coaching and mentoring.
- Assess resource needs to ensure thatan appropriatelevel of quality support is provided with the competencies needed.
- Develop direct reports by securing appropriate training assigning progressively challenging tasksand providing regularwritten and verbal performancefeedback.
- Ensure that appropriate risk management processes are in place focused on softwarerelated risks including design cybersecurity and data integrity risks.
- Lead overseeor participate in multiple portions of the Quality System including but not limited to Management Review Internal Audit Audit Readiness CAPA Document Control Training Product Release and others as needed.
- Be an effective member of the crossdepartmental Functional Management Team to foster continuous qualitycompliance cost andefficiencyimprovements.
- Complywith U.S. Food and Drug Administration (FDA) regulations other regulatory requirements Company policies operating procedures processes and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees customers contractors andsuppliers.
- Ensure sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
Required Qualifications:
- Bachelors degree preferably in EngineeringComputer ScienceLife Science or closely related discipline.
- 9 years of experience in a Quality Regulatory or product development role in the medical device industry.
- 5 years of experience managing a team of technical/quality professionals.
- Knowledge of FDA regulations and guidance ISO 13485 Software Standards (e.g. IEC 62304 EU Medical Device Regulations and MDSAP
Preferred Qualifications:
- Direct experience with SDLC for Cloudbased medical device networks and mobile medical device applications
Required Experience:
Senior IC
Employment Type
Full-Time
