Revance · 13 hours ago
Quality Management System (QMS) Engineer
Johnson City, TN
Full-time
Onsite
Mid Level
3+ years expRevance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings. The Quality Management System (QMS) Engineer is responsible for supporting the maintenance of the Medical Device Quality Management system and developing innovative solutions to quality, regulatory, and operational-related activities.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Ensure efficient and compliant processes throughout the organization
Support international market expansion by controlling documentation and product release prior to market entry
Provide quality oversight to cross-functional teams around the world
Develop quality plans for integration of new entities or devices into the QMS
Assist in development of Quality Agreements
Implement new quality initiatives within the site, including implementing corporate and site-specific policies and procedures
Support ISO 13485, EU MDR, FDA 21 CFR Part 820 Compliance Site QMS
Support preparation and hosting of external Quality System inspections
Support development, maintenance, and implementation of processes and procedures in accordance with regulatory requirements
Implement procedures and SOPs for QA/QC and ISO audits of Receiving, Receiving Inspection, Inventory, Manufacturing, Manufacturing Test, In-process Inspection, Final Inspection, Engineering, Pre-production, New Product Development, Customer Service, Training, Purchasing, Shipping, and Documentation, as well as other departments that effect quality, GMPs, and other regulatory requirements
Coordinate and assist in corrective and preventative action activities and solutions
Perform statistical analysis of data and write technical reports
Support other quality functions, which may include QA/QC sampling plans, supplier development, and quality training initiatives
Assist QMS Manager in reviewing and investigating customer complaints received per MDR’s, FDA, and ISO requirements; investigate reported product problems and complaint activity trends related to supplier quality
Review customer complaint investigations and trend analysis to identify corrective action opportunities
Monitor, maintain and assist with validation, sterilization, risk management and design activities
Provide ROSS Product Master and Recipe support to Marketing and Operations for component and labeling updates for the existing product, along with support for new product launch and/or transfer
Work collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans
Support activities and procedures associated with the Device Master Record (DMR) and Device History File (DHF); support all activities with the batch records/device history record (DHR)
Assist with maintaining the Risk Management Files and participate in Risk Analysis of changes; participate in the Risk Management Team
Assist with maintaining and managing the Software Lifecycle requirements per IEC 62304
The employee may be asked to perform other tasks related to his/her competence
Qualification
Required
Bachelor's degree & 3+ years' directly related experience
Extensive knowledge of the requirements of FDA QSR, ISO 13485 and 14971 and applicable worldwide regulations (eg. EU-MDR, Canada, AU, etc.)
Strong communication skills at all levels within the organization, and with Suppliers
Ensure efficient and compliant processes throughout the organization
Support international market expansion by controlling documentation and product release prior to market entry
Provide quality oversight to cross-functional teams around the world
Develop quality plans for integration of new entities or devices into the QMS
Assist in development of Quality Agreements
Implement new quality initiatives within the site, including implementing corporate and site-specific policies and procedures
Support ISO 13485, EU MDR, FDA 21 CFR Part 820 Compliance Site QMS
Support preparation and hosting of external Quality System inspections
Support development, maintenance, and implementation of processes and procedures in accordance with regulatory requirements
Implement procedures and SOPs for QA/QC and ISO audits of Receiving, Receiving Inspection, Inventory, Manufacturing, Manufacturing Test, In-process Inspection, Final Inspection, Engineering, Pre-production, New Product Development, Customer Service, Training, Purchasing, Shipping, and Documentation, as well as other departments that effect quality, GMPs, and other regulatory requirements
Coordinate and assist in corrective and preventative action activities and solutions
Perform statistical analysis of data and write technical reports
Support other quality functions, which may include QA/QC sampling plans, supplier development, and quality training initiatives
Assist QMS Manager in reviewing and investigating customer complaints received per MDR's, FDA, and ISO requirements; investigate reported product problems and complaint activity trends related to supplier quality
Review customer complaint investigations and trend analysis to identify corrective action opportunities
Monitor, maintain and assist with validation, sterilization, risk management and design activities
Provide ROSS Product Master and Recipe support to Marketing and Operations for component and labeling updates for the existing product, along with support for new product launch and/or transfer
Work collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans
Support activities and procedures associated with the Device Master Record (DMR) and Device History File (DHF); support all activities with the batch records/device history record (DHR)
Assist with maintaining the Risk Management Files and participate in Risk Analysis of changes; participate in the Risk Management Team
Assist with maintaining and managing the Software Lifecycle requirements per IEC 62304
Preferred
Bachelor's degree, or equivalent combination of training, education and/or experience in Science, Engineering, or Manufacturing-related field
2+ years' quality engineering experience
2+ years' Medical Device experience
Auditing experience in quality assurance requirements associated with medical devices
ISO 13485 Certified Lead Auditor or CQA
Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods
Strong project management skills as well as an ability to multitask
Ability to write reports, audit responses, and procedures
Ability to respond internally to common inquiries or complaints from customers, regulatory agencies, or members of the business community
Ability to effectively present information to top management, groups and/or boards of directors
2+ years' experience inside and outside the USA warehousing processes with 3PLs, licensing, and distribution
Knowledge of FDA Quality System requirements, ISO 13485:2016 (Quality System) requirements, ISO 14971:2019 (Risk Management) requirements, Medical Device Regulation (MDR) requirements, and Current Good Manufacturing Practices (cGMP)
Experience with IEC 62304 Software Lifecycle requirements
Proficiency with Microsoft Office products, including Excel, Word, PowerPoint, and Outlook
ETQ – Reliance experience
ROSS (ERP) system experience
Excellent attention to detail and communication skills, both written and verbal
Good analytical and statistical problem-solving skills/tools
Strong ethical standards
Travel up to 10%, both domestic and international
Benefits
Competitive Compensation including base salary and annual performance bonus.
Flexible PTO, holidays, and parental leave.
Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!
Company
Revance
We believe that science-powered innovation creates possibilities.
1001-5000 employees
H1B Sponsorship
Revance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (16)
2023 (8)
2022 (10)
2021 (16)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$1.68BKey Investors
Athyrium Capital Management LPEssex Woodlands Healthcare PartnersMedicis Pharmaceutical
2024-08-12Acquired
2024-03-04Post Ipo Equity· $100M
2022-09-12Post Ipo Equity· $200M
Leadership Team
Nadeem Moiz
Chief Executive Officer
Steve Kreider
Executive Vice President, Chief Revenue Officer - Aesthetics and Therapeutics
Recent News
MarketScreener
2025-10-27
Company data provided by crunchbase