Quality Engineer

Quality Engineer

Do you have a passion for Quality and are looking for a new challenge and an exciting opportunity to advance your knowledge, skills and career in a great working environment? Would you like to have a job that allows you the freedom to make decisions, learn new skills, develop new programs, and drive excellence.  If this is you, Comar will reward your performance and offers competitive compensation and benefits.

We are looking for a hardworking and enthusiastic Quality Engineer who doesn’t mind spending time on a production floor, can make independent decisions, is able to dive into a technical manual and learn technical systems, but can also present themselves well to employees, customers and corporate managers.  If this is you, we hope you can join our Quality Systems dream team and help us drive Operational Quality.

Salary range: $80,000 - $90,000, DOE 

THE ROLE

 Operational Quality Improvement

• 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. Is able to walk a production floor, read technical manuals, and lead continuous improvement projects based on first-hand knowledge of floor operations. 

Quality Management System (QMS) Support

• 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.)

WE ARE LOOKING FOR:

• 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.  

Preferred Experience with the following:

• 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) preferred.
• Knowledge of lean manufacturing principals in a high volume and high complexity environment.
• Knowledge of injection molding and plastic assembly processes.

DO YOU HAVE…?

• 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).

If the answer is YES, don’t delay Apply Today!

Salary : $80,000 - $90,000