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QA / RA Engineer - Operations at Hill-Rom

Posted in Other 30+ days ago.

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Type: Full Time
Location: Batesville, Indiana

Job Description:

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.DescriptionJob Summary:
This QA/RA role is responsible for supporting R&D project teams through the New Product Development process for various medical devices at the Hill-Rom Batesville Business site. This position will also be responsible for participating on various Design Assurance improvement initiatives to improve the overall quality of new product designs and the company's regulatory compliance profile per 21CFR820.30 regulations.

Essential Duties and Responsibilities:
* Responsible for all QA/RA functions as a core team member on new product development (NPD) teams
* Prepares and manages all QA/RA required NPD deliverables as well as support the remainder of the team in developing a quality product that meets regulatory requirements
* Monitors the Design Controls portion of the quality system for compliance to regulatory and system requirements
* Responsible for ensuring compliance to product verification and validation regulations
* Facilitates and completes root cause analysis investigations when design challenges are encountered
* Ensures important design characteristics are properly identified for correct level of controls
* Actively participate and assist teams with Risk Analysis to include Risk Assessments, DFMEA/PFMEA's, etc.
* Facilitate and support various reviews throughout the project to include Product Safety Committee, Phased Gate Design Reviews and Post Launch Analysis
* Actively participate and/or lead Design History File audits and follow-on remediation efforts as required
* Provides training to ensure proper implementation and use of quality tools and procedures as required
* Enables rapid and effective correction of quality/regulatory problems in a manner that prevents reoccurrence
* Participates on various continuous improvement/process improvement teams
* Proficient with Quality System Regulations, Medical Device Directive, and ISO Quality System Standards
* Demonstrated ability to work and perform in team environments
* Excellent analytical decision making and problem solving skills
* Proven ability to resolve issues and participate in process improvement activities
* Track record of successful business and customer orientation
QualificationsEducation and/or Experience:
* 3+ years of Quality/Regulatory experience required
* B.S. in Engineering or other 4 year Bachelor's Degree required
* Experience in a medical device company / industry required
* Experience in New Product Development/Design Controls required
* Experience with 510(k) preparation and submission desired
* CQA, CQE or RAC desired
Hill-Rom is an equal employment employer F/M/Disability/Vet/Sexual Orientation/Gender Identity img height=1 width=1 border=0 src= /