Quality Engineer

QUALITY ENGINEER

Our Quality team has an immediate opening at our plant in Saddlebrook NJ, for a Quality Engineer who is ready to take their career to the next level. As a Quality Engineer at Comar you will be a critical member of the team, bringing new products to market, continuously improving our processes, and ensuring the highest quality standards are met in support of our customers and the patient or end user of our products. Are you an Engineer looking to make a difference with a company that values teamwork, innovation, and professional growth? One of our Core Values is “Work Together, Win Together.” Come work and win with us today!

At Comar, we’re passionate about progress and finding opportunity in new ideas. In fact, we live by the motto: “Progress Never Stops.” Comar exists to deliver creative solutions that help enhance and extend lives. From our very founding more than 70 years ago to where we are today with a growing footprint across the globe, Comar has focused on developing solutions that make life better. Whether it’s a medical device, a drug delivery system, or a packaging solution, our products play a vital role in directly impacting consumers lives across the globe. Through a distinct blend of fresh thinking, engineering edge, and customer focus–we bring transformative packaging and medical solutions from concept to reality, where they can positively impact the world around us.

What you will do:
Operational Quality Improvement
· Execute pilot program activities directed by the Quality Manager supporting the 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 (Work Instructions, Process
Maps -PMs, Standard Operating Procedures- SOPs, Forms)
· 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 9001, 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 continues improvement 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 Administration (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 SQF procedures/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.

Additional Responsibilities & Skills for our SQF Certified Sites:   

• Have a basic understanding of the cGMPs and Good Hygiene Personnel Practices  

• Notify SQF Practitioner and/or Supervisor of any repairs or adjustments that are required.  

• Perform Basic Sanitation Functions  

• Perform all duties necessary to meet Company, and or Regulatory Requirements / standards as prioritized by the Company, HACCP, and SQF.  

• Notify SQF Practitioner/Quality Manager or any other Management personnel of ANY Food Safety or Quality issues.  

• Identify problems relating to Food Safety and the Quality of the raw material, processes, quality system, or safety system, by performing Production/Quality Checks as assigned.  

• Ability to initiate action to prevent the occurrence of nonconformities relating to Food Safety and the Quality of the product, processes, quality system, or safety system. Be able to execute and follow the HOLD SOP.  

• Controls further processing or delivery of nonconforming products in terms of Food Safety and Quality issues until the deficiency or unsatisfactory condition has been corrected.  
• Prepares and evaluates detailed product specifications and executes part activation workflows to support product development and production readiness.

• Employees follow all Food Fraud/food Defense Policies while on company property.  

• Thorough understanding of all Company policies, including GMP’s and safety policies, HACCP & SQF.  

Who we’re looking for:
· Bachelor’s degree completed for technology, engineering, science or significant applicable
experience, training, and certifications.
· 1- 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 and with the
validation of manufacturing and inspection processes.
· Experience with visual inspection standards and processes and experience with performing
training for plant-floor personnel.
· Knowledge of the safety requirements and complexity of working with automated and semi[1]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.
· Knowledge of ISO 9001, QS9000 and other Quality Management Systems

The entry point salary for this role is $77,000 annually. We reserve the right to offer compensation above the stated salary reflective of years of technical experience, skillset, relevant industry experience, complexity, etc. This position is eligible for a comprehensive benefits package including medical, dental, 401(k), tuition reimbursement, and additional ancillary benefits available upon request.

Ready to take the next step in your career? Apply today

Salary : $77,000