Revance · 15 hours ago
Quality Engineer, Medical Device
Johnson City, TN
Full-time
Onsite
Mid, Senior 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 Engineer, Medical Device is responsible for maintaining the quality system and developing solutions to quality-related problems, ensuring compliance with quality control guidelines and assisting in the design and implementation of policies for testing and evaluating products.
BiotechnologyHealth CarePharmaceuticalTherapeutics
Responsibilities
Support company goals and objectives, policies and procedures, in compliance with quality systems, FDA regulations, and all other external regulatory requirements for which product is distributed
Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to cGMP and ISO 13485:2016 within the Operations, Quality, and Regulatory processes. Provide written reports and supporting documentation for recommendations
Provide quality engineering support to manufacturing/kitting, along with support for new product launch and/or transfer
Develop and implement quality control process sampling systems (skip-lot), procedures, and statistical techniques
Perform statistical analysis of data and write technical reports
Ensure accurate project schedules are maintained and communicated
Support other quality functions, which may include QA/QC sampling plans, supplier development, and quality training initiatives
Present data analysis and trend information to management and other groups as required
Responsible for the corrective action report process (CAPA)
Manage and track the corrective action reports to ensure action(s) are taken in a timely manner
Review and investigate 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
Ensure Nonconformance process is followed per procedure and provide technical input; identify and develop solutions to recurring issues, along with communication to nonconformance team
Support internal/external/corporate audits
Evaluate data and identify trends related to Nonconformance/Quality Holds, as needed; collaborate to develop innovative solutions and communicate to management
Lead problem-solving efforts to identify and resolve recurring and new quality issues, to ensure production of safe and effective medical devices
Work collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans
Support Document Control initiatives and consult on continuous improvement activities involving the document control program; assist with eQMS activities
Manage 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; lead efforts with completing a full risk assessment of the receiving, kitting, and shipping of products (PFMEA/Risk Analysis)
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
Support company goals and objectives, policies and procedures, in compliance with quality systems, FDA regulations, and all other external regulatory requirements for which product is distributed
Assess, provide recommendations, and lead implementation of systems, processes and equipment for improvement and compliance to cGMP and ISO 13485:2016 within the Operations, Quality, and Regulatory processes
Provide written reports and supporting documentation for recommendations
Provide quality engineering support to manufacturing/kitting, along with support for new product launch and/or transfer
Develop and implement quality control process sampling systems (skip-lot), procedures, and statistical techniques
Perform statistical analysis of data and write technical reports
Ensure accurate project schedules are maintained and communicated
Support other quality functions, which may include QA/QC sampling plans, supplier development, and quality training initiatives
Present data analysis and trend information to management and other groups as required
Responsible for the corrective action report process (CAPA)
Manage and track the corrective action reports to ensure action(s) are taken in a timely manner
Review and investigate 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
Ensure Nonconformance process is followed per procedure and provide technical input; identify and develop solutions to recurring issues, along with communication to nonconformance team
Support internal/external/corporate audits
Evaluate data and identify trends related to Nonconformance/Quality Holds, as needed; collaborate to develop innovative solutions and communicate to management
Lead problem-solving efforts to identify and resolve recurring and new quality issues, to ensure production of safe and effective medical devices
Work collaboratively with Operations and R&D project teams to develop and implement appropriate risk management, qualification, verification, and validation plans
Support Document Control initiatives and consult on continuous improvement activities involving the document control program; assist with eQMS activities
Manage 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; lead efforts with completing a full risk assessment of the receiving, kitting, and shipping of products (PFMEA/Risk Analysis)
Assist with maintaining and managing the Software Lifecycle requirements per IEC 62304
Preferred
Bachelor's degree, or equivalent combination of training and/or experience in Science, Engineering, or Manufacturing-related field
5+ years' quality engineering experience
3+ 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 multi-task
Ability to write reports, business correspondence, 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 board of directors
Thorough 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%, 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