Quality Engineer

Comar; Buena (NJ); On-site; USD 69,000 - 85,000; Full time

Benefits offered by this job

Medical benefits

Dental insurance

401(k) plan

Job summary

Comar is seeking a Quality Engineer at our Buena, NJ plant to advance product quality, support new product introductions, and drive continuous improvement across manufacturing processes. You will work within a cross-functional team to ensure compliant practices and robust quality systems.

The role emphasizes practicing cGMP/ISO standards, leading CAPA and deviation handling, and mentoring plant staff toward quality excellence and sustained process improvements.

Qualifications

• Bachelor's degree or higher in technology, engineering, science, or related field.
• Experience in manufacturing quality environments and quality systems.
• Strong writing, data analysis, and procedural documentation skills.

Responsibilities

• Improve operational quality and support pilot programs.
• Lead CAPA investigations and corrective actions with cross-functional teams.
• Ensure compliance with FDA cGMP, ISO 13485/9001 standards and internal SOPs.
• Develop and maintain QMS documents, work instructions, SOPs and forms.
• Perform training and competency assessments of plant personnel.

Skills

Quality engineering

Regulatory compliance

CAPA investigations

GMP/ISO knowledge

Root cause analysis

Education

Bachelor's degree in Engineering

Tools

QMS documentation

Job description

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, Trending, etc.) Identifying opportunities for Continuous Improvement, defining value and implementation.

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 semiautomated 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

The compensation entry point 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.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.