WORK SHIFT
DAY (United States of America)

SUMMARY OF DUTIES
Provides quality engineering support for products and processes while completing projects in broad areas of assignment supporting design transfer activities. Fulfills requirements associated with product development, design controls, and product risk management. Ensures that the products are designed, tested, and manufactured in compliance with all applicable agency/internal quality requirements and optimizing quality systems and documentation.

ESSENTIAL FUNCTIONS PERFORMED
• 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 and mentor 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 a variety of other tasks and related work, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS
• Lifting -- Not to exceed 50 lbs. - local practice may apply.
• Writing
• Sitting
• Standing
• Bending
• Visual acuity
• Color perception
• Depth perception
• Reading
• Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

• Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
• A minimum of eight (8) 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.

PREFERRED QUALIFICATIONS

• Medical device experience or equivalent experience in a regulated industry.
• Experience with Minitab or JMP, Oracle.
• Passed ASQ Certified Quality Engineering exam.

COMPETENCIES

• Interpersonal Skills
• Organization
• Written and Verbal Communication
• Teamwork
• Conflict Resolution
• Negotiation
• Problem Solving
• Decision Making

COMMENTS

Infectious Control Risk Category II:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.