Quality Engineer

PROMED MOLDED PRODUCTS INC•Plymouth, MN

19d•$82,780 - $114,236

About The Position

The Quality Engineer serves as a lead quality representative for assigned product lines, supporting new product development, day-to-day manufacturing, non-conformance management, and independent review. The role also supports Supplier Quality, internal audits, and the Corrective and Preventive Action Procedure for Good Manufacturing Practice (CAPA). The Quality Engineer helps ensure efficient operations and continuous production of parts that meet established standards and customer expectations. The position operates with minimal guidance from management or senior staff and ensures that ProMed’s brand, philosophy, systems, policies, and procedures are properly implemented and observed. The role partners with Operations and Engineering to provide quality guidance, investigate production issues, develop and implement production controls, analyze data, and drive corrective actions and process improvements. It also supports process, equipment, component, and product qualification and validation, as well as new product development.

Requirements

Engineering or science degree with a drug- or medical-device-related background and at least 3 years of experience in the field.
Experience in the medical or cleanroom industry.
Knowledge of medical device regulations (21 CFR 4, 210, 211, and 820), ISO 13485, and risk management (ISO 14971).
Intermediate knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Project.
Commitment to company-wide continuous improvement.
Excellent written and verbal communication and interpersonal skills; professional, courteous, and friendly manner; ability to convey and receive information effectively.
Excellent organizational, problem-solving, and time-sensitive skills.
Ability to build positive working relationships with a diverse group of people across gender, ethnicity, age, culture, and skill levels.
Ability to establish priorities and meet deadlines.

Nice To Haves

Professional certification, such as ASQ or Six Sigma.
Proficiency in statistical, quality, and continuous improvement methods and tools.
Knowledge of Coordinate Measuring Machines (CMM), pin gages, calipers, and other measurement equipment as required.
Knowledge of Statistical Process Control (SPC), Minitab, SQC pack, design of Methodology, and blueprint reading.
Problem-solving and critical-thinking skills.
Strong interpersonal, written, and verbal communication skills, including the ability to convey ideas and receive information effectively.
Self-starter with a proven ability to work successfully with minimal supervision.
Professional, courteous, and friendly personality.
Working knowledge of spoken and written English.

Responsibilities

Adhere to 21 CFR 820, 210, and 211 and ISO 13485.
Develop or revise standard operations and working practices, conduct training on revised practices, and review documentation and records for compliance.
Represent quality in daily manufacturing in assigned departments, partnering with Operations and Engineering and providing guidance consistent with external and internal standards and best practices.
Develop and maintain relationships with production leads and production personnel.
Lead engineering investigations into production issues.
Facilitate development and implementation of production processes and controls, including qualification, process capability, sampling plans, and validation.
Analyze statistical data and product specifications to evaluate standards and achieve targeted quality and repeatability.
Assist with investigations of product non-conformance and complaints, root cause analysis, process and product monitoring and trending, issue escalation, and implementation of corrective actions.
Plan, draft, and route change requests as needed.
Identify or resolve dimensional characterization methodologies and inspection criteria.
Evaluate and recommend process improvements.
Qualify and validate processes and equipment to meet customer and ProMed objectives.
Identify customer needs and manufacturing capabilities that can support future growth.
Create and review process Failure Mode and Effects Analyses (pFMEAs) for new projects and existing production lines.
Identify actions to reduce or eliminate failure occurrence and process variables that can reduce occurrence or improve detection of failure conditions.
Perform data analysis and generate reports for new product development and production projects.
Review prints and provide recommendations based on Design for Manufacturing principles.
Manage execution and report generation for gage repeatability and reproducibility (Gage R&R) studies.
Manage and execute component qualification, validation, and equipment qualification.
Support new product development as needed.
Maintain regular, reliable attendance and perform other duties as necessary and appropriate.