Quality Specialist

The Quality Specialist will manage quality records, assist in investigation and resolution of defects, engage with new product development deliverables, plan and execute test activities for software features, and ensure post market surveillance is consistent with applicable regulations, standards, and established procedures.

DUTIES AND RESPONSIBILITIES:

• Develop, implement, and maintain test methodologies, test plans, protocols, test scripts, test reports and traceability matrices for MediView platforms. Resolve complaints, nonconformances and CAPAs to support post-market evaluation and data analysis.
• Analyze data from test activities, interpret results, and prepare technical documentation to provide visibility into product readiness, quality, and reliability.
• Conduct functional, performance, reliability and Human Factors testing of devices to ensure compliance with quality standards and regulations.
• Perform manual testing of new software features and interfaces.
• Document and track defects and bugs, and, with assistance from Software Quality Assurance, analyze root causes and follow up on fixes.
• Partner with other members of the Quality team to develop, implement, and maintain test methodologies, test plans, protocols, test scripts, test reports and traceability matrices for MediView platforms.
• Assist in triage, investigation, and resolution of software and hardware defects.
• Identifies plans and executes test process improvements to continually improve the performance of the Quality team and QMS at large.
• Provide quality support to design teams; this includes input into the bench and pre-clinical test requirements and participating in risk management meetings and related activities such as verification of risk mitigation implementation in products and processes as needed.
• Support Internal Quality Audits and support the audit program as needed.
• Support health authority audits and external audits.
• Proactively drive continuous improvement initiatives related to the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Collaborate with regulatory affairs to ensure testing procedures meet industry standards and compliance requirements.
• Perform all activities in compliance with the Quality System.
• Perform all other duties as assigned.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Education and/or Experience – Bachelor’s degree in engineering is preferred. Minimum of 2 years’ experience in the medical device industry developing class II and class III devices. Experience working with engineering team to partner and understand system requirements is preferred. Experience with conducting Human Factors Engineering evaluations is preferred.
• Software Platform – Working knowledge of document control, eQMS, and other software platforms utilized within the medical device industry.
• Language Skills – Strong communication skills such as written, verbal, and public speaking. Ability to read, analyze, and interpret common scientific and technical journals. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to management, public groups, and/or board of directors. Ability to interact clearly and effectively, in both written and oral communication, with supervisor, clients, staff, vendors, etc.
• Mathematical Skills – Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Computer Skills – To perform this job successfully, an individual should be proficient in personal computer skills including electronic mail, record keeping, routine database activity, word processing, spreadsheet, graphics, etc. This role requires an above-average knowledge of Microsoft Office.
• Other Qualifications - Valid driver’s license is required; Must be able to travel 20-30% of the time; Overnight stays may be necessary. Experience and ability to work in a fast-paced, tech startup environment where change is a constant and roles and tasks can be ambiguous at times.
• Knowledge of medical device product development life cycle, including design controls, risk management, software configuration, design verification and validation.
• Strong working knowledge of IEC 62304, FDA Quality System Regulation, General Principles of Software Validation, ISO 13485, ISO 14971, and other related medical device regulations.

PHYSICAL DEMANDS:

While performing the duties of this job, the individual must be able to remain in a stationary position for 90% of the time while operating their computer and performing office work. The individual needs to occasionally move about inside the office. They must be able to exchange accurate information with customers and others in the office while interacting. The employee must regularly lift and/or move up to 15 pounds, occasionally lift and/or move up to 30 pounds.

WORK ENVIRONMENT:

The noise level in the work environment is usually low to moderate. The individual frequently works in a controlled climate. May be in clinical or hospital environments where health may be at risk due to exposure from patients that may have infectious diseases.