Quality Engineer

Comar•Woodville, WI

2d•Hybrid

About The Position

Comar is seeking a hardworking and enthusiastic Quality Engineer who is passionate about Quality and looking for a new challenge to advance their knowledge, skills, and career in a great working environment. This role offers the freedom to make independent decisions, learn new skills, develop new programs, and drive excellence. The ideal candidate will be comfortable spending time on a production floor, capable of diving into technical manuals, learning technical systems, and presenting themselves well to employees, customers, and corporate managers. The Quality Engineer will be a key member of the Quality Systems team, focusing on driving Operational Quality, supporting the Quality Management System (QMS), and leading investigations into customer complaints, Non-Conformance Reports (NCR), and Corrective and Preventive Actions (CAPA).

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.
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

Medical device manufacturing environments.
Visual inspection standards and processes.
SPC, Control Charts, Cp, Cpk, Histograms, data analysis.
Performing training for plant-floor personnel.
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.
Ability to program and operate automated inspection equipment (Zeiss CMM, Keyence Vision Systems, Zeiss Vision and Touch probe systems, Various Inspection hand tools).
Strong understanding of GD&T, Print Reading and the ability to analyze SPC data.
Investigate Customer complaints, Non-Conformance Report (NCR), Corrective and Preventive Action (CAPA), and lead Continuous Improvement.
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.).