Hill-Rom is a $2.7B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions.
Hill-Rom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry. This role is responsible for providing QARA oversight for product development activities, maintaining the non-product validation program, and coordinating product recall activities at the Hill-Rom Cary location.
ESSENTIAL DUTIES AND RESPONSIBILITIES: – Other duties may be assigned:
Serves as the Quality & Regulatory stakeholder for product development release team
Ensures quality products are developed in accordance to governing regulations and processes
Prepares all QARA product development deliverables
Serves as key member of product risk assessment teams
Drives key quality requirements (e.g. Design for Test, Design for Reliability, etc.) in new product development
Participates and supports various development activities including design reviews and Product Safety Committee
Reviews and approves product design documentation
Actively participates and/or leads Design History File audits and follow-on remediation efforts as required
Support root cause analysis activities for the investigation of product complaints
Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEA’s, etc.
Assists in the planning and execution of verification and validation testing to ensure adequate test coverage for new products and sustaining design changes.
Assists in planning and execution of engineering change orders for hardware and software-related product changes
Performs New Product Development (NPD) gate audits to ensure project deliverables adhere to governing processes
Responsible for managing all tool and process validations – reviews and approves all validation documentation
Maintains Master Validation List (MVL) and facilitates annual review of MVL
Reviews quality data to identify high priority issues relating to safety, complaints and systemic customer satisfaction
Responsible for product change assessments, health hazard evaluations and product recall documentation
Assists with CAPA investigations and ensures corrections and/or corrective actions for identified nonconformances are implemented
Participates in site visits with customers and customer feedback workshops
Identifies and implements process improvement initiatives, especially scalable, risk-based processes
Works with other Hill-Rom entities to establish Communities of Practice in Risk Management, Software Quality Assurance, Software Development, and other strategic areas as required.
B.S. in Engineering (Electrical, Biomedical, etc.) or other technical degree
3+ years’ experience in quality engineering / quality assurance role under the Quality System Regulation, medical device or other FDA regulated industry required
Experience in New Product Development/ Medical Device Design Controls required
Experience with software-based products required
Extensive experience with quality tools and methods required (e.g. DFSS, root cause analysis, Software FMEAs, etc.)
Knowledge of Medical Device Directive, and/or ISO Quality System Standards desired
Experience with requirements management tools and systems engineering concepts desired
CQA, CQE, CSQE, or RAC certification desired
Excellent analytical decision making and problem solving skills
Ability to partner with individuals to build relationships throughout the Hill-Rom Corporate organization
Demonstrated ability to work and perform in team environments
Employer will assist with relocation costs.
Internal Number: 18122081
Hill-Rom is a $2.7B leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.
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