Quality Engineer
Comar

Job Info

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Quality Engineer

“Come build a Career with our Growing, Fast-Paced, Customer-Focused Company that fosters Training & Professional Development!”

Are you a Quality professional with a passion for Quality Engineering 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 rewards performance and offers competitive compensation and benefits?

We are looking for a hardworking and enthusiastic Quality & Manufacturing Engineer to join our Quality Systems dream team and help us drive Operational Quality in our newest facility.

THE ROLE

Operational Quality Improvement

• Execute pilot program activities directed by Quality Systems Manager supporting Operations Manager
• Ensure compliance to program checklist activities and lead corrective actions for errors
• Understand and communicate the performance and quality gains from strict adherence to best practices.
• Collaborate cross-functionally to create necessary QMS documents (WIs, PMs, SOPs, Forms)
• Ensure understanding and training to responsibilities within the plant Quality Department.

Quality Management System (QMS) Support

• Follow applicable requirements of FDA cGMP, ISO 13485, ISO 9001, ISO 14971, FDA 110/210/211, GFSI, Process Validation et. al.
• Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports.
• Analyze and summarize data for validations, CAPA, and Comar “TPI3” CI initiatives.
• Internal Auditing of adherence to procedures
• Manage the Visual Factory Layered Process Audit process and report out on deficiencies and actions
• Monitor impact of plant-floor, process or setting changes on the validated state of the lines
• Create, modify, and approve (with other SMEs) deviations and change control requests for documents, equipment, and processes
• Track open deviations and change controls for proper closure and resolution.

Food & Drug Adm (FDA), International Standards Organization (ISO), medical device and pharmaceutical industry best practices.

• Identify needs, aid development and presentation of education & training materials with Comar University.
• Perform personnel assessments of competency.
• Monitor and enforce adherence to clean room/Good Manufacturing Practices (GMP)/industrial hygiene practices.
• Consistently deliver messaging about following procedures and fixing issues so they can be followed.
• Complete Safety Training Observation Program (STOP) audits and GEMBA (Lean Manufacturing and Kaizen) continuous improvement audits as assigned, ensure Quality Department actions from audits closed.
• Develop and maintain personal training plan to stay current on cGMP requirements

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.
• Lead corrective action effort for systemic risks.
• Document investigations and improvements using analysis of data (ANOVA, Cpk, Trending, etc.)
• Identifying opportunities for Continuous Improvement, defining value and implementation.

WE ARE LOOKING FOR:

• Bachelor’s degree completed for technology, engineering, science or significant applicable experience, training, and certifications.
• 0- 3 years’ experience in Manufacturing or Quality Engineering.
• Experience with Technical writing of reports, data analysis, customer response correspondence, and procedure manuals.

Preferred:

• Experience working in medical device or food manufacturing environments.
• Experience with visual inspection standards and processes.
• Experience with performing training for plant-floor personnel.
• Experience with the validation 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.
• For Medical Device Sites: Knowledge of Regulated Industry (CFR Part 820 Quality System Requirements, the ISO family of standards, particularly ISO 13485 and 9001, others as the corporation certifies to them).
• For non-Medical Device Sites: Knowledge of ISO 9001, QS9000 and other Quality Management Systems.

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

#CB

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