Quality Engineer

Comar•Town of Eau Galle, WI

11h•Onsite

About The Position

Comar is seeking a hardworking and enthusiastic Quality Engineer who is passionate about Quality and looking for a new challenge. This role offers an exciting opportunity to advance knowledge, skills, and career in a great working environment, with the freedom to make decisions, learn new skills, develop new programs, and drive excellence. The ideal candidate will be able to make independent decisions, dive into technical manuals, learn technical systems, and present themselves well to employees, customers, and corporate managers. The Quality Engineer will join the Quality Systems team to drive Operational Quality.

Requirements

Two Year Technical degree completed for technology, engineering, science or significant applicable experience, training, and quality or manufacturing engineering certifications
Experience with Technical writing of reports, data analysis, customer response correspondence, and procedure manuals
Strong understanding of GD&T, Print Reading and the ability to analyze SPC data
Ability to effectively present information and respond to questions from groups of managers and cross-functional co-workers
Ability to define problems, collect data, establish facts, and draw valid root cause conclusions based upon data
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Ability to read technical drawings, dimensions, tolerancing
Ability to learn and quickly become computer user efficient: PC-based and/or equipment-based HMI’s GUI’s (human-machine interfaces, graphical user interfaces) for production and inspection equipment
Ability to interpret input from technical staff and Engineering to apply risk-based thinking on the proposed activity or change to a process or equipment
Ability to interact effectively with all levels within the company
Knowledge of Regulated Industry (21 CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001, others as the corporation certifies to them)

Nice To Haves

Experience with Medical device manufacturing environments
Experience with Visual inspection standards and processes
Experience with SPC, Control Charts, Cp, Cpk, Histograms, data analysis
Experience performing training for plant-floor personnel
Experience with Validations of manufacturing and inspection processes
Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment
Knowledge of vision inspection systems, and PLCs (programmable logic controllers for factory automation)
Knowledge of lean manufacturing principals in a high volume and high complexity environment
Knowledge of injection molding and plastic assembly processes

Responsibilities

Develop, initiate, and drive continuous improvement activities directed by the Quality Manager and supporting the Operations Manager
Collaborate with engineering and operational teams to implement new procedures or drive continuous improvement projects
Develop and draft written work instructions and training programs to ensure adherence to quality standards and objectives
Work in both an office environment but also takes a "hands on" approach to troubleshooting production quality issues
Walk a production floor, read technical manuals, and lead continuous improvement projects based on first-hand knowledge of floor operations
Follow applicable requirements for FDA cGMP, ISO 13485, guidelines
Analyze and summarize statistical data for validations and day to day operations
Take part in Internal Auditing to ensure compliance to regulatory standards and company procedures
Program and operate automated inspection equipment (Zeiss CMM, Keyence Vision Systems, Zeiss Vision and Touch probe systems, Various Inspection hand tools)
Use critical thinking and problem-solving skills to determine root causes of issues (5 Why, Fishbone, 8D, Is/Is-Not)
Lead and/or facilitate Operations and Quality cross-functional investigations
Determine corrections, corrective actions, and verification of effectiveness
Analyze data and trends within the CAPA process to determine systemic risks
Document investigations and improvements using analysis of data (Cpk, control charts, histograms, etc.)