CaryRecruiter Since 2001
the smart solution for Cary jobs

Senior Quality Systems Specialist

Company: Hill-Rom
Location: Cary
Posted on: April 4, 2021

Job Description:

\n\n Description \n\n \n\n JOB SUMMARY: \n\n \n\nThe Senior Quality Systems Specialist will support Quality System Management functions for Hillrom Care Communications located in Cary, NC, Jupiter and Sarasota, FL. The role will have direct interaction with leaders and directors across various functions at both the local and corporate levels. The Senior Quality Systems Specialist will be responsible for managing the Corrective and Preventative Action program including nonconformance evaluations, root cause analysis, and assisting with compliance audits.\n\n \n\n ESSENTIAL DUTIES AND RESPONSIBILITIES: Other duties may be assigned as needed: \n\n \n\n Primary areas of ownership, responsibility and accountability: \n\n \n\nManages the Corrective and Preventive Actions (CAPA) system to ensure regulatory compliance and effectiveness across the business through driving collaboration, direction, management, and oversight of the CAPA process\n\n \n\nManages nonconformance evaluations, assists with correction development and CAPA escalation assessment\n\n \n\nCollaborate with internal departments and CAPA owners with Root Cause Analysis, Action Plans and Effectiveness Checks\n\n \n\nChairs the site level CAPA review boards and ensures that CAPA action plans are effective and managed in a timely manner\n\n \n\nProvides training, coaching, and consultation to business partners as it relates to the CAPA and Non-conformance processes\n\n \n\nAssists with coordinating and executing the internal audit program to ensure regulatory compliance and effectiveness\n\n \n\nParticipates in notified body and regulatory audits as required assisting with audit preparation, facilitation, and audit response\n\n \n\nAssists with the application of the Hillrom supplier quality program for Care Communications to ensure the implementation and effectiveness of supplier quality development initiatives and supplier performance management\n\n \n\nProvides oversight and direction for supplier evaluations and supplier quality systems/manufacturing process audits\n\n \n\n Qualifications \n\n \n\n EDUCATION, EXPERIENCE AND QUALIFICATIONS: \n\n \n\nBachelor of Science; with 5 years of Experience in Quality Assurance desired\n\n \n\nExperience in a medical device industry and knowledge of Quality System Regulations (QSR 21CFR) required\n\n \n\nSound knowledge and exposure to Medical Device Regulations (FDA, MDD/MDR, MDSAP etc.) related ISO/IEC standards (ISO 13485, IEC 62304, ISO 14971, MDDS, TIRs etc.) desired\n\n \n\nCollaborator, Self-Starter, Quick Learner, with excellent analytical decision making and problem-solving skills\n\n \n\nExcellent written and verbal communicator & influencer with good interpersonal and the ability to build partnerships\n\n \n\nAbility to travel -10% for training, seminars, audits & inspections\n\n \n\n PHYSICAL REQUIREMENTS: \n\n \n\nNOTE: The inability to perform any of the following physical requirements does not preclude an applicant from consideration unless, following an individualized analysis, it is determined that the physical requirement is an essential job function and the applicant is unable to perform such function with or without reasonable accommodation\n\n \n\n Job: Quality\n\n \n\n Primary Location: United States-North Carolina-Cary\n\n \n\n Schedule Full-time\n\n \n\n Travel Yes, 10 % of the Time\n\n \n\n Posting Entity Hillrom\n\n \n\n Req ID: 21122298\n\n

Keywords: Hill-Rom, Cary , Senior Quality Systems Specialist, Other , Cary, North Carolina

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Babysitter/Nanny Needed For 2 Children In Burlington
Description: Burlington family needs a part-time babysitter for twin girls. Weekly schedule may vary slightly depending
Company: Care.com
Location: Burlington
Posted on: 04/11/2021

Naval Aviator
Description: ABOUT br br Search for underwater threats. Deliver payloads of incredible firepower or necessary manpower. Execute strategic aerial maneuvers anywhere from the stratosphere, to mere feet above the (more...)
Company: Navy
Location: Chapel Hill
Posted on: 04/11/2021

Direct Support Professional - Residential
Description: Danville-Pittsylvania Community
Company: DANVILLE PIITSYLVANIA COMMUNITY SERVICES
Location: Danville
Posted on: 04/11/2021


Plant Cost Accountant
Description: Job LocationsUS-NC-WilsonYour OpportunityThe Finance/Accounting team is seeking out driven, detail-oriented professionals to exercise GAAP principles while preserving the superior financial standing of (more...)
Company: Smithfield Foods
Location: Wilson
Posted on: 04/11/2021

Utility Operator 2nd Shift
Description: o Comply with Good Manufacturing Practices GMPs . br br o Work safely and comply with all safety rules. br br o Minimize the creation of waste
Company: Refresco
Location: Wilson
Posted on: 04/11/2021

Chiropractor
Description: Full TIME Chiropractor DC Needed in Greenville, NC We are currently seeking a Full-time Chiropractor DC to join a growing practice
Company: Healthcare Recruitment Counselors
Location: Rocky Mount
Posted on: 04/11/2021

Sr. Customer Assistance Representative
Description: Overview The Customer Assistance Representative Sr CAR Sr will provide a high level of customer service by assisting both internal and external customers, primarily face-to-face, supporting their branch (more...)
Company: Enterprise Rent-A-Car
Location: Rocky Mount
Posted on: 04/11/2021

Utility Worker
Description: Overview:Transdev is the largest private sector operator of multiple modes of passenger transit in North America, providing bus, rail, paratransit, shuttle, sedan and taxi services. We manage over 200 (more...)
Company: Transdevna
Location: Burlington
Posted on: 04/11/2021

Deliver with Grubhub (part time, full time, any time!) - Apply Immediately!
Description: Grubhub Delivery PartnerApply to be a delivery partner with Grubhub and work on your own time Grubhub needs delivery partners like you Are you looking for a flexible way to earn extra cash Deliver (more...)
Company: GrubHub
Location: Rocky Mount
Posted on: 04/11/2021

Human Intelligence Collector (35M)
Description: Intelligence is crucial to the security of our nation. By gathering information about an adversary's intentions, strengths, vulnerabilities, and capabilities, the military can plan, prepare, and defend (more...)
Company: Army National Guard
Location: Burlington
Posted on: 04/11/2021

Log In or Create An Account

Get the latest North Carolina jobs by following @recnetNC on Twitter!

Cary RSS job feeds