Quality Engineer

Location: Buena

QUALITY ENGINEER

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.

Our Quality team has an immediate opening at our flagship Buena, NJ plant 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!

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 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 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 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,…