Description

Summary:   

The Quality Engineer is responsible for supporting and maintaining the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, and customer-specific requirements. This role focuses on the investigation and resolution of product and process nonconformances, managing CAPA and SCAR processes, coordinating MRBs, and ensuring SOPs are properly implemented and followed. The Quality Engineer also plays a key role in preparing for and supporting internal, external, and customer audits. Additional responsibilities include providing training to operators on quality requirements, procedures, and Good Documentation Practices (GDP) to ensure compliance and consistency across manufacturing activities. 

Essential Duties and Responsibilities: 

•       Support, maintain, and improve the Quality Management System (QMS) to ensure regulatory and customer compliance.
•       Lead or participate in Corrective and Preventive Action (CAPA) investigations, ensuring thorough root cause analysis, effective     corrective actions, and timely closure.   
•      Review and disposition NCRs; coordinate Material Review Boards (MRBs) to drive effective decision-making on nonconforming   materials and parts.
•       Manage Supplier Corrective Action Requests (SCARs), follow up with suppliers on corrective actions, and ensure customer concerns are resolved promptly.
•       Draft, revise, and maintain SOPs, work instructions, and quality procedures to ensure consistency, clarity, and compliance.
•       Act as a key participant in internal audits, customer audits, and third-party audits; provide documentation, lead audit responses, and ensure timely follow-up actions.
•       Track and report on quality metrics such as CAPA trends, SCAR closure rates, NCR frequency, and audit outcomes; provide data-driven insights to management.
•       Support lean and Six Sigma initiatives, process validations, and risk management activities to improve product quality and process capability.
•       Provide training to operators on quality procedures and GDP requirements to ensure proper documentation and compliance. 

Qualifications: 

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

•       Bachelor’s degree in Engineering, Quality, or related technical field (or equivalent experience).
•       2+ years of experience in quality engineering within medical device, pharmaceutical, or regulated manufacturing environment.
•       Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and related quality system requirements.
•       Experience with CAPA, NCRs, MRBs, SCARs, SOPs, and audit preparation.
•       Excellent documentation, communication, and organizational skills.
•       Proficient with Microsoft Office; experience with electronic QMS software preferred. 

Preferred Qualifications:

•         Experience in injection molding, precision manufacturing, or medical device production.
•         Minitab experience
•         Experience in Medical Device (ISO 13485) manufacturing industry
•         Knowledge of ISO 9001/134855/FDA requirements and compliance
•         Familiarity with GD&T, metrology equipment (CMM, optical systems), and statistical analysis tools (Minitab/Excel).
•         Ability to speak with customers 
•         Strong problem-solving and cross-functional teamwork abilities. 

Education/Experience: 

•       College education preferably in an engineering field
•       Minimum of 1-5 years of hands-on experience desired 

Language Ability: 

Ability to read, write, understand and follow instructions in the English language.

Effective oral and written communication in the English language

Spanish is a plus 

Certificates and Licenses: 

None 

Supervisory Responsibilities: 

None 

Work Environment:

Typical machine shop environment, requiring safety glasses.  Employees are required to follow company policies and procedures (located in the company handbook) related to proper dress attire and safety.  

Physical Demands: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Mobility to stoop, bend, lift, and move from one workstation to another, alternately sitting and standing
Ability and stamina to work more than 8 hours per day
Ability to communicate effectively with customers