Quality Engineer

Quality Engineer Comar
• Saddle Brook, NJ, United States

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.

• 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.

• Follow applicable requirements of FDA cGMP, ISO 9001, FDA 110/210/211, GFSI, Process Validation, etc.
• Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports.
• Analyze and summarize data for validations, CAPA, and Comar continuous improvement initiatives.
• Internal audit 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…