This job is closed
Applications are no longer available for this announcement. Explore current related opportunities below.
Job description
Overview:
Tympanogen is a medical device company based in Richmond, VA with a mission to improve healthcare by simplifying surgical procedures. We develop gel-based medical devices for the ear, nose, and throat industry and are preparing to launch our first product.
Job Description:
Quality Systems
Support, maintain and continuously improve the existing company electronic Quality Management System (eQMS) in accordance with regulatory requirements; especially requirements specified in 21 CFR Part 820, ISO 13485, ISO 14971 and other global medical device regulations
Develop and implement post-market quality plan and documents alongside manufacturing efforts in accordance with regulatory requirements
Interpret and provide guidance on applicable and upcoming federal and international regulations and implement updates to company eQMS as necessary
Apply process analysis/development tools to create and continuously improve procedures required to maintain compliance and business efficiency (e.g., fishbone diagrams, flowcharts, statistical applications)
Support manufacturing and product development teams in design transfer and iterative product development
Generate and improve metrics required to establish the overall suitability and effectiveness of the QMS
Participate in Design Reviews and Risk Management reviews
Assist in maintaining and updating internal and external standards. Work with Subject Matter Experts to ensure gap analysis is performed to ensure continued compliance
Provide technical support for company personnel regarding the eQMS
Lead internal and external audits and audit-preparation activities
Develop, administer, and continuously improve the training required to support the effectiveness and suitability of the eQMS. This requirement includes the development, implementation and maintenance of specific Instructor-Led Training courses such as cGMP Compliance, Good Documentation Practices, Risk Management and Process Development
Responsible for handling complaints, non-conformances, and the CAPA process
Responsible for creating a Management Review Process and serves as the Management Representative
Document Control
Responsible for creating and supporting the Document Control functions within the eQMS
Ensure the consistency and quality of documents within the change control process
Perform process training for document creation and document control processes
Quality Control
Assists team in investigating and documenting non-conformance issues, determining root causes and implementing corrective actions
Resolves document issues and facilitate sampling or rejection of materials in a timely manner
Responsible for implementing a Quality Control program to monitor manufacturing processes and support product release
Create a Product Release process for consistent batch release including label reconciliation, batch review and generation of appropriate Quality certificates.
Supplier Management
Establish and maintain a robust supplier and supply management program including supplier/supply qualification, SCAR process and ongoing monitoring
Establish and oversee the supplier audit program
Position Requirements
Background Experience
4-year technical degree in engineering or a scientific discipline
8 years in an FDA-regulated medical device environment
Certified Quality Manager or Certified Quality Auditor Certification(s)
Experience in developing and improving quality management systems
Knowledge of documentation systems, specifically new product development (protocols, reports, software, validation data, Design History Files), quality systems (procedures, forms, quality records), and manufacturing (Bill of Material, travelers, procedures, Device History Records, Device Master Records).
Direct experience maintaining procedures as they relate to the FDA Quality System regulations and ISO 13485
Exposure to 21 CFR Part 11 and Computer/Quality System Software management methods
Experience with ISO 14971 and applying a risk-based approach to product development and manufacturing
Quality and business process knowledge
Familiarity with FDA, ISO 13485, ISO 14971 Quality Systems and Risk Management requirements
Ability to identify and recognize how the quality management system potentially affects the wider business of the company
Ability to apply a practical level of statistics
Ability to develop and maintain spreadsheets, pivot tables, metrics, statistical applications, charts/graphs and user-friendly reports
Ability to use process development tools
Working knowledge of quality control and lot release sampling plans
Leadership skills
Prior experience managing at least one direct report
Demonstrated ability to communicate and interact with all levels of the organization including management
Strong interpersonal skills to provide coaching, training, and direction
Individual skills
Above-average organizational and prioritization skills
Detail-oriented while being flexible and able to adapt to changing priorities is required
Strong proofreading and writing skills, as well as exemplary attention to detail
Strong decision-making including the ability to rapidly understand complex changes and pace work completion to the needs of the company
Demonstrated initiative and ability to work independently while handling multiple tasks
Strong computer knowledge (MS Office), technical writing skills and proofreading ability
Ability to learn new electronic platforms for communication, project management, and documentation
Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required
Compensation
Base salary range: $150,000-170,000
Paid holidays, PTO, medical, dental, vision plans
401(k) with matching program
Eligible for annual bonus and equity awards
#J-18808-Ljbffr
Worksite address
richmond, VA, 23214, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.