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HealthfirstDirector, Performance Improvement
Director of Performance Improvement responsible for PI initiatives and team leadership at Healthfirst. Collaborating with operations to enhance business processes and productivity measures.
About the role
- Leading the development, establishment and maintenance of Quality Assurance and Engineering programs in the STS team.
- Define and influence a quality culture that enables both rapid transformation of ideas to requirements to products and diligent and deliberate compliance to internal quality management system requirements in design and development.
- Manage, mentor, and develop Quality Engineers on approach to design controls, agile design, risk management and product security.
- Build strong partnerships with cross-functional leaders to drive continuous improvement efforts, through facilitating, leading, and collaborating effectively.
- Manage and monitor day to day activities to ensure compliance with company policies and procedures (e.g. compliance with FDA, BSI, CSA, etc.).
- Align software validation practices across BD.
- Manage quality metrics and present them in management reviews.
- Provide Design and Development leadership during FDA and Notified body site inspections.
- Interface with the FDA on Pre-Market Activities: Design Controls, Risk Management, Test Methods, Safety Assurance Case, Human Factors.
- Maintain effective design-related Quality Metrics and define and execute activities to improve performance.
- Actively identify improvements to the processes within the QMS to enhance both compliance and quality.
Requirements
- Bachelor's degree in engineering, computer science, or life sciences.
- 15+ years of experience in software design and development within Medical Device regulated industry.
- Experience managing software quality engineering teams and leading complex software projects.
- ASQ certifications (CQA, CQE, CSQE, CMQ) are a plus.
- Expert knowledge of software development lifecycle and test methodologies.
- Strong understanding of design controls, risk management, and product security.
- Familiarity with regulatory standards including ISO 13485, IEC 62304, and 21 CFR.
- Experience in Agile/SAFe methodologies is preferred.
- Experience in Cloud/SaaS software product development is preferred.
Benefits
- Competitive package of compensation and benefits programs
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