Quality Management System (QMS) Engineer

Revance • Johnson City, TN

3d • Onsite

About The Position

The Quality Management System (QMS) Engineer is responsible for supporting the maintenance of the Medical Device Quality Management system, and for developing and coordinating innovative solutions to quality, regulatory and operational-related activities. Extensive knowledge of the requirements of FDA QSR, ISO 13485 and 14971 and applicable worldwide regulations (eg. EU-MDR, Canada, AU, etc.) are necessary. The QMS Engineer supports strategic direction, establishes efficient and compliant processes throughout the organization, and has strong communication skills at all levels within the organization, and with Suppliers.

Requirements

• Bachelor’s degree & 3+ years’ directly related experience.

Nice To Haves

• 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.

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.

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!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees