Principal QA Design Transfer Engineer

February 10

🚗 Michigan – Remote

Although this job is listed in Michigan, this company may be open to hiring remote in other states.

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Merit Medical Systems, Inc.

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As a global healthcare company, we understand customer needs and innovate and deliver medical solutions that transform patient care.

Medical devices • inflation devices • catheters • guide wires • custom angiography kits

5001 - 10000 employees

💰 Post-IPO Debt on 2023-06

📋 Description

• Participates in design and development activities assuring the design requirements are appropriately transferred into manufacturing. • Guides the design team as subject matter expert of Design Control from Design Inputs through Design Outputs, Process Validation, Test Method Validation and Device Master Record creation. • Responsible for coordinating risk analysis/management activities. • This may include leading risk management analysis meetings, documenting results, following up to ensure risk mitigation and facilitating improvements. • Reviews, approves, and generates Engineering Change Notifications (ECNs) to update or generate verification, validation, monitoring and inspection methods, procedures, and test protocols; specific to assigned product line(s) and processes and production control(s). • Conducts complete and conceptually related studies to approach technical problems, where the problems are difficult to define, require unconventional or novel approaches, and require sophisticated research techniques. • Performs technical work where available guides and precedents contain critical gaps, are only partially related to the problem, or may be largely lacking due to the novel character of the project. • Contributes techniques which are of material significance to solve specific problems and drive continuous improvement. • Keeps abreast of new scientific methods, standards, regulations, and developments affecting the organization for the purpose of recommending changes to processes, systems or designs warranted by such developments. • May plan, organize, mentor, and supervise the work of engineers or technicians on various engineering projects and quality system compliance issues. • Mentors and evaluates competency of Quality Auditors, Design Assurance/Quality Engineers, and technicians, by providing training or other actions required to satisfy quality objectives. • Reviews nonconformance records (internal/external) to determine disposition, root cause, and need for corrective and preventive actions. • Ensures containment (identification, segregation, and reconciliation) of nonconforming product has been performed, to prevent unintended use. • Identifies and implements any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of quality policy, quality objectives, audit results, analysis of data, risk management, etc. • Evaluates the work environment in which product is manufactured, and ensures it is adequately controlled and monitored, with sufficient personnel and safety production controls. • May support Internal Audit and supplier audit activities, performing audits, writing audit reports, and following up on effectiveness of corrective/preventative actions. • Performs other duties, as required.

🎯 Requirements

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field. • Fifteen (15) years of engineering experience. • Demonstrated working knowledge of 21 CFR 820 (Quality Systems Medical Devices), ISO 13485, ISO14791, and other medical device related standards. • Working knowledge of statistical methodologies, quality control and manufacturing tools such as problem solving, root cause investigation, applied statistics, lean manufacturing, Six Sigma, etc., and project management experience. • Knowledge of applicable regulatory agency regulations. • Demonstrated computer skills, preferably spreadsheets, word processing, database, and other applicable software programs.

🏖️ Benefits

• Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights • Medical/Dental & Other Insurances (eligible the first of month after 30 days) • Low Cost Onsite Medical Clinic • Two (2) Onsite Cafeterias • Employee Garden | Gardening Classes • 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays • 401K | Health Savings Account