“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 Corporate Quality Engineer to join our Quality Systems dream team and help us drive Operational Quality at our manufacturing facilities.
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.
Ensure understanding and training to responsibilities within the plant Quality Department.
Quality Management System (QMS) Support
Able to 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 Admin. (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.
Minimum 2 years’ experience in Manufacturing or Quality Engineering.
Experience with Technical writing of reports, data analysis, customer response correspondence, and procedure manuals.
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 with 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!
Enthusiastic:Shows intense and eager enjoyment and interest
Detail Oriented:Capable of carrying out a given task with all details necessary to get the task done well
Dedicated:Devoted to a task or purpose with loyalty or integrity
2 years:Experience with Technical writing of reports, data analysis, customer response correspondence, and procedure manuals.
2 years:Minimum 2 years’ experience in Manufacturing or Quality Engineering.
2 years:Knowledge with injection molding and plastic assembly processes.
2 years:Knowledge of lean manufacturing principals in a high volume and high complexity environment.
2 years:Knowledge of vision inspection systems, and PLCs (programmable logic controllers for factory automation) preferred.
2 years:Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment.
2 years:Experience with the validation of manufacturing and inspection processes.
2 years:Experience with performing training for plant-floor personnel.
2 years:Experience with visual inspection standards and processes.
2 years:Experience working in medical device or food manufacturing environments.
Additional Salary Information: Competitive salary and benefits
Internal Number: CORPO01364
About Comar LLC
Packaging Quality, Service, and Creativity Since 1949
We have a longstanding reputation for developing creative, industry-compliant, rigid plastic solutions for the Medical, Pharmaceutical, Consumer Healthcare, Personal & Home Care, Food & Beverage, and other niche markets. Focused on quality, service, and creativity for more than six decades, we are your trusted partner to execute and unlock growth.