Quality Systems Manager at Hill-Rom in Milwaukee, Wisconsin

Job Description:

Hillrom is a $2.8B 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. Hillrom'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.DescriptionPosition Summary: The Quality Systems Manager is responsible for management, administration and continuous improvement of the documented quality management system.

Position Responsibilities:
* Ensure the proper functioning and continued effectiveness of Quality System procedures, maintaining compliance with required standards and regulations (e.g. ISO 13485, ISO 9001, FDA QSR, MDD, Canadian MDR, etc.).
* Acts as primary Subject Matter Expert on Quality Management Systems for Hillrom.
* Leads development and implementation of improvements to the Quality Management System across the organization.
* Provide leadership, direction and training to Quality System procedures.
* Oversees the CAPA program and site Corrective Action Board (CAB). Ensures linkages between site-level CAB and corporate Global CAB.
* Ensure proper functioning of corrective and preventive action system and effectiveness of changes implemented.
* Oversees and provides education in quality and quality tools for the organization.
* Primary representative for activities and communications associated with internal, customer and regulatory audits performed at Hillrom; ensure resolution of reported non-conformances.
* Maintains the internal audit plan/schedule and coordinates audit activities to ensure company requirements are met. Acts as Lead Auditor for internal audits.
* Provides metrics related to quality system processes and quality objectives for Management Review.
* Write, review and approve quality system documents.
* Assist in preparation of annual budget request.
* Performs other duties as requested.
QualificationsRequired:
* Bachelors of Science degree in engineering or a related field.
* At least 8 years relevant experience within the regulated industries.
* Certified Lead Auditor training or relevant experience.
* Experience with audits (FDA, Notified Body and Certification Testing Laboratories).
Preferred:
* American Society of Quality Certification.
* Proficient in the Microsoft Suite: Excel, Word.
* Fluent in English (both written and oral).
* Ability to read written electrical schematics.
* Excellent written and verbal skills, strong analytical skills.
* Leadership skills and abilities: * Ability to lead others and get results through others.
* Ability to develop employees beyond their current abilities.
* Ability to delegate.

* Behavior skills and abilities: * Ability to work under minimal supervision.
* Ability to work well in groups.
* Ability to work in a fast-paced high stress environment.
* Calm under pressure.
* Good listening skills.
* Open to new ideas, proactive, ability to learn new skills and concepts easily, flexibility and adaptability, good organizational and planning skills, and detail orientated.

Hillrom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity img height=1 width=1 border=0 src=https://hillrom.contacthr.com/78499692.jpg /