Job Description:

Quality Systems

• Develop, support, maintain and continuously improve the company Quality Management System (QMS) in accordance with regulatory requirements; especially requirements specified in the 21 CFR Part 820, ISO 13485, ISO 14971 and other global medical device regulations
• Interpret and provide guidance on applicable and upcoming federal and international regulations
• Apply process analysis/development tools to develop and continuously improve procedures required to maintain compliance and business efficiency (e.g., fishbone diagrams, flowcharts, statistical applications)
• 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 electronic QMS platforms
• 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 QMS. 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.
• Assist in administrating the equipment calibration and preventive maintenance program
• Responsible for qualifying suppliers, services and supplies and maintaining the supplier files
• Responsible for handling complaints, non-conformances, and the CAPA process

Document Control

• Responsible for creating and supporting the Document Control functions within the QMS
• Ensure the consistency and quality of documents within the change control process
• Perform process training for document creation and document control processes
• Implement and maintain process for ensuring only current document revisions are available for use

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QA Operations

• Assist in reviewing and approving Lot History Records to ensure product is dispositioned according to established process
• Perform Lot-Release activities and generate Certificates of Compliance for all devices released for sale
• Review and approve label proofs
• Responsible for maintaining and archiving quality records including LHRs, Equipment Files, Nonconformance records and other records as necessary

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Quality Control

• Helps develop sampling requirements for QC lot release testing
• Assists team in investigating and documenting non-conformance issues, determining root causes and implementing corrective actions
• Interfaces with R&D team to coordinate QC activities for manufacturing support
• Coordinate with procurement personnel, suppliers, and management for resolution of any issues associated with received reagents, supplies and documents
• Resolves document issues and facilitate sampling or rejection of materials in a timely manner

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Position Requirements:

Background Experience:

• Position requires a 4-year technical degree in engineering or a scientific discipline
• 3+ years in an FDA-regulated medical device environment
• Certified Quality Manager or Certified Quality Auditor Certification(s) preferred
• Experience in developing or 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 preferred
• Exposure to 21 CFR Part 11 and Computer/Quality System Software management methods preferred
• Experience with ISO 14971 and applying a risk-based approach to product development and manufacturing

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Quality and business process knowledge:

• Familiarity with FDA, ISO 13485, ISO 14971 Quality Systems 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

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Leadership skills:

• Demonstrated ability to communicate and interact with all levels of the organization including management
• Strong interpersonal skills to provide coaching, training, and direction

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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