Quality Systems Specialist II - Inogen

Job Summary:

The Quality Systems Specialist has the responsibility for ensuring the organizational compliance with quality and regulatory standards for both product and company operations. This position will support the Quality Management System; including creation, revision and implementation of company SOP’s and work instructions. The Quality Systems Specialist will assist in the identification of potential compliance issues and gaps and recommend and/or verify implementation of appropriate corrective/preventive actions.

Responsibilities (Specific tasks, duties, essential functions of the job)

• Review Document Change Requests for accuracy and submit for routing and approval in a timely manner.
• Manage archiving, retrieval and retention of Quality Records.
• Inspect, test and sample materials, parts, or products for defects and any deviations from specifications.
• Assist in ensuring that all elements of the quality system are in compliance per regulatory requirements.
• Analyze document change request and submit for approval in a timely manner.
• Provide guidance to change owners, system users and other internal customers.
• Collect and analyze data and report metrics for CAPA’s, NCR’s and Inspections in accordance with established in processes and procedures.
• Identifying, prioritizing, communicating, and resolving quality related issues.
• Manage the external standards management process by ensuring new standards are procured, changes to current standards, and/or new standards are identified along with the associated implementation timelines. Ensure integration of new or revised management system standards (i.e. ISO 13485, ISO 14971, IEC 62304, etc) are understood and integrated into the system.
• Manage the customer complaint handling process and the initial completion and review of customer complaints which are escalated for further review.
• Participate (as is needed) in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
• Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
• Support key business relationships by providing Quality expertise specific to contract manufacturing, private label arrangements, due diligence for possible acquisitions, etc.
• Assist in compiling, submitting, and monitoring reports and responses to regulatory authorities.
• Support regulatory agency inspections/audits and Supplier audits.
• Participate in the Internal Audit Program as an internal auditor.
• Assist in the Corrective and Preventive Action (CAPA) process to ensure CAPA’s are issued out and completed in a timely manner.
• Participate in company-wide quality management system training and provide Quality systems expertise.
• Support Lean and Kaizen initiatives to introduce improvements throughout the quality management system.
• Support Operations reporting and trending.
• Maintain regular and punctual attendance.
• Comply with all company policies and procedures.
• Assist with any other duties as assigned.

Quality Systems Specialist II

In addition to items listed for Quality Systems Specialist I, Quality Systems Specialist II may also be responsible for the following:

• Limited sign off for Quality.
• Lead Corrective and Preventive Action (CAPA) program facilitation efforts.
• Lead internal and external audit efforts.

Knowledge, Skills, and Abilities

• Experience in medical device Regulatory Affairs and at least one (1) of the following: product development, manufacturing engineering, quality assurance, or production management.
• Ability to support external/ internal audits.
• Attention to detail and process improvement capabilities.
• Knowledge of DMEPOS accreditation requirements preferred.
• Experience with DMEPOS/CMS preferred.
• Knowledge of ISO 14001 required.
• Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verifying process improvements.
• Familiarity with process improvement concepts (i.e., LEAN Six Sigma).
• Must have strong work ethic.
• Excellent oral and written communication skills are required.
• Attention to detail is required.
• Must demonstrate effective conflict resolution.
• Analytical and problem-solving skills and ability to multitask are required.
• Must be solutions-oriented problem solver.
• Excellent planning, communication and organizational skills are required.
• Ability to effectively interface with different departments within the company is required.

Qualifications (Experience and Education)