Job Overview
We are seeking a dynamic and detail-oriented Quality Engineer/EMS (Environmental Management System) Coordinator to join our manufacturing team. In this pivotal role, you will drive quality assurance initiatives, ensure compliance with industry standards, and coordinate environmental management practices across production processes. Your energetic approach will help foster a culture of continuous improvement, regulatory adherence, and operational excellence. The ideal candidate will possess a strong background in quality systems, manufacturing standards, and regulatory compliance, with a passion for elevating product quality and environmental stewardship.

Duties

• Establish quality standards based on customer requirements and as per IATF 16949, ISO 13485 and ISO 14001 standards
• Develop and maintain process quality documentation up to date with any improvements or new customer requirements.
• Support customer requirements and be responsive for any compliant or nonconformance reported.
• Support and manage Quality Technicians (QAT) in production floor.
• Participate in daily production meeting to review any issues, follow actions related to quality and support to resolve issues related to quality.
• Handle internal and external corrective actions with 8D reports and manage in designated systems, follow actions with other departments and communicate with customers.
• Manage hold inventory, set priorities and monitor reports for material disposition.
• Support with material returns from customers under RMAs.
• Perform statistical and capability analysis of new and ongoing parts using SPC software
• Support as internal auditor and during customer or 3rd party audits;
• Support calibration process and system and related studies;
• Support to develop APQP documents, i.e. Control Plans, FMEAs, etc;
• Review and approve medical batch records.
• Assist in any Quality activities in plant, including but not limited to, assisting Quality Manager with customer or corporate reports and for plant Quality issues;
• Assist with special studies as required;
• Perform training to required personnel for inspection methods, quality requirements and documentation;
• Coordinate the maintenance, audits and improvement of the ISO 14001 Environmental Management System as EMS coordinator.
• Manage documentation related to quality control procedures, audit reports, non-conformance reports (NCRs), and compliance records.

Education

• Bachelor's degree in Engineering, Environmental Science, Quality Management, Industrial Technology, or a related field.
• Equivalent combination of education and experience may be considered.

Experience

• 3–5 years of experience in a quality engineering, quality management, environmental management, or related role.
• Experience with ISO 9001 and ISO 14001 management systems preferred.
• Manufacturing environment experience preferred.
• ASQ certification as Quality Engineer, desired.

Knowledge, Skills and Abilities

• Strong knowledge of Quality Management Systems (QMS) and Environmental Management Systems (EMS).
• Understanding of ISO 9001 and ISO 14001 requirements.
• Knowledge of root cause analysis methodologies, including 5 Why, Fishbone Diagram, and CAPA.
• Proficiency with Microsoft Office Suite and quality data analysis tools.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and projects simultaneously.
• Ability to interface effectively with Department Heads and customers.

Skills

• Strong understanding of regulatory/legal compliance standards in production settings across various industries.
• Excellent analysis skills for root cause analysis, data interpretation, and problem-solving within complex manufacturing processes.
• Effective team leadership abilities combined with strong cross-functional communication skills to foster collaboration across departments

Join us to be part of a forward-thinking organization committed to excellence in manufacturing quality and environmental responsibility!

Benefits:

• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Work Location: In person