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.DescriptionESSENTIAL DUTIES AND RESPONSIBILITIES: - Other duties may be assigned
* Supports validation and risk build activities with supplier manufacturing and engineering group
* Conducts supplier audits and manages audit corrections meet deadlines
* Performs root cause analysis and implements effective corrective action for supplier nonconformance and manages SCARs to meet deadlines
* Assesses supplier quality performance using statistical and analytical methods
* Establishes relationships with suppliers and actively drives continuous improvement
* Assists with customer complaint investigations and dispositions
* Initiates non-conforming dispositions
* Initiates CRs and COs through change process
* Develops and implements test methods and procedures for inspecting, testing and evaluating product and processes
* Participates with Supply Chain in supplier selection process and purchased materials cost reductions
* Develops gauging methodology for products
* Performs capability studies and gage R&R
* Continuously identifies areas of improvement in the incoming inspection processes that would enhance product quality, along with implementing the improvements
* Conducts trend analysis: collects data, creates, updates and maintains trend charts and reports
* Analyzes improvement opportunities through MRB monitoring
* Ensures products and processes comply with regulatory and QSM requirements
* Performs FAI for new product and product changes
* Conducts SNAP process
* Develops trainings to build quality awareness
* Reviews and approves risk management/risk analysis documents
* Participates in PFMEA and DFMEA reviews
* Participates and provides input in design review meetings, partnering with NPD and Manufacturing during the entire development and transfer process
QualificationsEDUCATION, EXPERIENCE, QUALIFICATIONS AND SKILLS:
* Bachelor's degree in Engineering or a technical field is preferred
* 3+ years' experience responsible for Quality improvement projects
* 1+ years' experience in a regulated industry that includes FDA and ISO requirements
* ASQ certification a plus
* Displays developed communication and interpersonal skills: leadership, team orientation, ability to communicate at all levels
* Is flexible and adaptable to make effective decisions and maintain effectiveness under changing circumstances and priorities
* Teamwork, communication, positive attitude required to support the manufacturing environment
* Ability to read and analyze technical prints and drawings
* Problem Solving ability to perform root cause analysis and implement effective corrective actions
* Ability to effectively manage and complete multiple projects simultaneously
* Ability to conduct Process Failure Mode and Effect Analysis (PFMEA)
* Excellent computer skills including but not limited to Microsoft Office Suite
QUALITY AND REGULATORY REQUIREMENTS:
* Knowledge of quality system including the quality manual, quality policy and applicable procedures and work instructions
* Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulation, ISO 13485, European Union Medical Device Directives, and Canadian Medical Device Regulations
Hill-Rom is an equal employment employer F/M/Disability/Vet/ Orientation/Gender Identity
Employer's Job# 65836693
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