Quality Engineer

Job Summary

Role Overview:

• Provide quality engineering support for daily manufacturing activities, quality systems, and design projects.

Position Summary:

· Provide support and oversight for daily manufacturing activities.

· Develop and improve manufacturing and quality system procedures.

· Collaborate on and facilitate CAPA, NC, and Complaint investigations, corrections, and corrective actions.

· Implement change controls and provide training to employees.

· Partner with Engineering, Operations, and Clinical to generate and evaluate risk-based evidence supporting critical business and patient safety decisions.

· Partner effectively with colleagues, customers, suppliers, contract manufacturers, and external stakeholders to ensure alignment on quality and risk-related objectives.

· Ensure compliance with FDA regulations, EU MDR requirements, ISO standards, company policies, and global regulatory expectations while championing a proactive risk-based quality culture.

· Review and analyze requirements, specifications, and design documents to ensure full test coverage for lot release.

· Create comprehensive test planning documents for existing and new products

· Support customer and third party audits.

· Support administration and implementation of the quality management system.

Skills and Requirements:

· BS Engineering, Science, or related discipline and 7-10 years of experience with manufacturing, quality assurance, and/or quality management systems in the medical device industry.

· Working knowledge of FDA QMSR, ISO 13485, ISO 14971, EU MDR, etc.

· Experience in a contract manufacturing environment

· Strong analytical/problem solving, including knowledge of root cause investigation methodologies and statistical/data analysis

· Excellent verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization.

· Experience working with some or all of the following technologies is desirable:

o Class II and III Medical Devices,

o Active implantables,

o cleanroom manufacturing,

o electronics manufacturing including ESD controls

o Software validation

o eQMS/ERP implementation

o packaging/labeling

o Sterilization

Pay: $76,600.00 - $92,300.00 per year

Benefits:

• Dental insurance
• Health insurance

Work Location: In person