Quality Assurance Manager - Virginia, United States - Rivanna Medical

Rivanna Medical Virginia, United States

4 weeks ago

Description

RIVANNA is seeking a medical device Quality Assurance professional to contribute to our emerging medical device company's rapid growth.

You will work within a talented team of professionals as we strive to achieve our mission of improving global healthcare through innovative medical technology.

This is a hands-on multidisciplinary role in which the right candidate will actively manage different aspects of RIVANNA's quality management system and regulatory communications.

The position will report directly to the Director of Operations with substantial support from the operations team and external regulatory consultants.

Education and Requirements
Bachelor's degree in engineering, regulatory, quality assurance, or similar
4+ years of experience
Experience and training to MDSAP, ISO 13845, and FDA 21 CFR 820
Internal and external audit management experience
Experience with FDA pre-submissions and 510(k) applications
Responsibilities
Actively manage and improve the company's MDSAP and ISO 13485-certified quality management system (QMS)
Maintain and oversee RIVANNA's QMS (internal audits, management reviews, corrective and preventive actions, complaints, and supplier management)
Administer and develop company-wide quality management system training
Work with operations team to manage SOPs
Oversee internal audits
Act as management representative and coordinate external audits
Manage substantial change reporting
Perform registrations for Company products
Define and manage design transfer documentation, design history files, and technical files
Engage FDA through pre-submission and 510(k) applications
Support global product registration processes

RIVANNA Medical offers the following employee benefits: health insurance, vision and dental, group life, long-term disability, paid time off, 401(k) with match, and more.

We are always looking to complement our existing team with individuals who bring unique perspectives and experiences.

This variety of thought and perspective drives innovation and strengthens our ability to create an inclusive team environment where our core values of trust, humility, and dedication are practiced every day.

RIVANNA Medical is committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, sex (including childbirth, breastfeeding, and related medical conditions), gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability or any other protected status in accordance with all applicable federal, state and local laws.

All employees must be able to lift at least 25 pounds. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
About Rivanna Medical, Inc.
RIVANNA is a privately held designer, manufacturer, and distributor of world-first, imaging-based medical solutions based in Charlottesville, VA.

RIVANNA operates an FDA-registered and ISO 13485:2016 certified manufacturing facility where it produces the Accuro product line and related medical equipment and components.

Accuro is the world's ?rst spinal navigation device designed to improve safety, speed, and efficiency of spinal needle guidance procedures.

RIVANNA's revolutionary platforms feature BoneEnhance, Multi-Frequency Image Reconstruction, which optimizes ultrasound for the visualization of bony versus soft tissue anatomy, and SpineNav3D AI-Based Spine Recognition, which automates ultrasound image interpretation.

#J-18808-Ljbffr

Senior Information Assurance Manager/ Cybersecurity

5 minutes ago

Parsons Oman Virginia, United States

In a world of possibilities, pursue one with endless opportunities. Imagine Next · When it comes to what you want in your career, if you can imagine it, you can do it at Parsons. Imagine a career working with intelligent, diverse people sharing a common quest. Imagine a workplace ...
Assurance Manager or Director

1 week ago

CliftonLarsonAllen Virginia, United States

Assurance Manager or Director page is loaded · Assurance Manager or Director · Apply · locations · Arlington, VA · Greenbelt, MD · time type · Full time · posted on · Posted 3 Days Ago · job requisition id · R14191 · CLA is a top 10 national professional services firm ...
Quality Assurance Manager

3 weeks ago

V2X, Inc. Virginia, United States

Overview · Oversee the activity of the quality assurance deliverables to include: developing, implementing, and maintaining a system of quality and reliability testing for the organization's products and/or development processes. Oversee the quality management system standards e ...
Quality Assurance Manager

2 weeks ago

Comfort Keepers group Virginia, United States

You are applying for work with a Comfort Keepers franchisee, not CK Franchising, Inc. or any of its affiliates. If hired, the franchisee will be your only employer. Franchisees are independent business owners who set their own wage and benefit programs that can vary among franchi ...
Program Analyst

1 week ago

DoDEA Virginia, United States

Marine Corps Community Services (MCCS) is looking for the best and brightest to join our Team · MCCS is a comprehensive program that supports and enhances the quality of life for Marines, their families, and others in the Marine Corps Community. We offer a team oriented environm ...
Computer Lab

2 days ago

Caliber Systems Virginia, United States

CALIBRE is an employee-owned Management Consulting and Information Technology Solutions Company, looking for a qualified individual to serve as Computer Lab (SIPR) Coordinator at the Army Force Management School (AFMS). The primary function of the job is to maintain the accredita ...
Licensed Practical Nurse

3 weeks ago

Range Mental Health Center Virginia, MN, United States

Job Title: Licensed Practical Nurse · Job Classification: Non-Exempt · Supervisor: Nurse Manager · Location: Locations include Virginia, Hibbing and Ely with primary site in Virginia · Status: Full-Time, Part-Time & Casual · Benefits: Including but not limited to: Medical, Dental ...
RN Case Manager

1 week ago

Essentia Health Virginia, United States

Job Description · Job Description: · Responsible for organizing and providing care to patients through the process of assessment, planning, intervention, and evaluation. Supports the physician and interdisciplinary team to assure patient progress through the continuum of care to ...
Director, Quality Assurance

2 weeks ago

Appian Virginia, United States

Here at Appian, our core values of Respect, Work to Impact, Ambition, and Constructive Dissent & Resolution define who we are. In short, this means we constantly seek to understand the best for our customers, we go beyond completion in our work, we strive for excellence with inte ...
registered nurse

3 weeks ago

Range Mental Health Center Virginia, MN , USA, United States

Job Title: Registered Nurse · Job Classification: Non-Exempt · Supervisor: Nurse Manager · Location: Includes Virginia, Hibbing, and Ely, with primary service sites in Virginia · Status: Full-time, Part-time & Casual · Benefits: Including but not limited to: Medical, Dental, Life ...
Production Manager

3 weeks ago

Rivanna Medical Virginia, United States

RIVANNA is seeking someone to champion efficiency and quality assurance in our manufacturing operations. This exciting role involves overseeing inventory, production, and testing processes, as well as assembling and testing devices. Plus, you'll collaborate closely with our resea ...
Software Engineer Labor Category SWE3

3 weeks ago

2HB Incorporated Virginia, United States

This is a full-time position, and MUST HAVE a TS/SCI/Full Scope Polygraph Clearance. · 2HB Incorporated is seeking a Software Engineer in order to support its government customer in Mclean, VA . · INTRODUCTION · This is a full-time position, and MUST HAVE a TS/SCI/Full Scope P ...
QA Analyst

3 weeks ago

S3solutionsllc Virginia, United States

Quality Assurance Analyst II works directly with developers, business analysts and key business stakeholders and will be responsible for the manual testing of internal products as well as integrations to 3rd party products. This position will also be responsible for developing an ...
PKI Administration and Cyber Compliance Lead

2 days ago

ASRC Federal Holding Company Virginia, United States

PKI Administration and Cyber Compliance Lead - Sign-On Bonus · #AFHC-24814 · {{jcity}}{{jstate}} · Posting Location · 27130 TELEGRAPH RD, QUANTICO-VA072 · Functional Group · Information Technology · Job Title · PKI Administration and Cyber Compliance Lead - Sign-On Bonus ...
Information Assurance Security Officer

4 weeks ago

Janus Research Group Virginia, United States

Are you ready for new challenges and new opportunities?Join our teamCurrent job opportunities are posted here as they become available.Information Assurance Security Officer - RMF Information Systems Assurance Officer - RMFJob Description:The Sustainment Battle Lab is an experime ...
Systems Engineer, Lead

2 weeks ago

W R Systems Virginia, United States

Clearance Requirement: · Active Secret Clearance is required to start · Location: · Dam Neck · SUMMARY · : · WR has an opportunity for a Systems Engineer, Lead to independently analyze the performance of hardware and software interfaces and identify alternatives for optimizin ...
Quality Assurance Engineer

1 week ago

International Association of Plumbing and Mechanical Officials Virginia, United States

About Civica Civica is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce chronic generic drug shortages and related high prices in the United States. Civica is led by an experienced team of healthcare and pharmaceutical ind ...
Merchandiser Part Time

2 weeks ago

Viking Coca-Cola Virginia, United States Part time

Job Description · Job DescriptionPart Time Merchandiser - Virginia · BECOME A PART OF OUR TEAM: · If you're going to wear a team name on your work shirt, make it a WINNING TEAM. Make it one of the most recognized brand names in the World Imagine being a part of a winning, global ...
Software Engineer Senior

3 weeks ago

International Association of Plumbing and Mechanical Officials Virginia, United States

ECS is seeking a · Software Engineer Senior (PERL) · to work in our · Arlington, VA · office . · Job Description: · ECS is seeking a Perl software engineer. Engineers are responsible for creating and deploying new features within a web application.They research defects and cr ...
Senior Acquisition Consultant

1 week ago

Acquisition Professionals LLC Virginia, United States

Corporate Profile: · Acquisition Professionals (AP) LLC is a trusted strategic partner and solutions-based company that combines years of deep knowledge-based expertise, agile program management, and customized learning solutions, AP provides cradle-to-grave acquisition services ...