Quality Engineer

Salary Range: $82,779.66 To $ Annually

Team:
Quality

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

Team:
Quality

As a Pro Med employee, you will contribute to the manufacture of products that have a significant impact on people’s lives. Through honesty, integrity, and collaboration, we strive to be the very best as we hire the very best.

Pro Med was founded in 1989 addressing an industry need for cleanroom manufacturing of silicone components, specifically those having a medical application. We treat every component and finished device as though it will be used by a beloved family member or friend. We are dedicated to our customers and to our employees while helping to improve the health and well-being of people around the world.

The primary responsibility of this role is to serve as a lead representative of assigned product lines for new product development, day-to-day manufacturing support, non-conformance, and acts as the independent review function. The Quality Engineer supports additional processes such as Supplier Quality, Internal Audit, Corrective and Preventive Action Procedure for Good Manufacturing Practice (CAPA), etc., in order to effect operational efficiency and economy, the Quality Engineer ensures continuous production of parts consistent with established standards, and to meet the customer’s desired results.

This position operates under minimal guidance from management or senior staff. The Quality Engineer ensures Pro Med’s brand, philosophy, systems, policies, and procedures are properly implemented and observed.

Position duties and responsibilities include, but are not limited to the following:

• Adheres to 21
  
  CFR 820, 210, 211 and ISO 13485.
• Develops and/or revises standard operations and working practices;
• Develops and conducts training sessions related to revised practices; and
• Reviews documentation and records to ensure compliance;
• Be the voice of quality for daily manufacturing in assigned departments by partnering with Operations and Engineering and providing guidance on issues in line with external standards, internal standards, and best practices;
• Develops and maintains strong relationships with production leads and production personnel;
• Leads engineering investigations when production issues arise;
• Facilitates development and implementation of production processes and controls (i.e. qualification, process capability, sampling plans, validation, etc.);
• Analyzes statistical data and product specifications to evaluate current standards and achieve targeted quality and repeatability;
• Assists with investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, escalation of identified issues, and implements corrective action as it pertains to customer complaints and internal non-conformance;
• Plans, drafts, and routes change requests as necessary;
• Identifies and/or resolves dimensional characterization methodology and inspection criteria;
• Evaluates and recommends process improvements;
• Qualifies/validates processes and/or equipment to meet customer and Pro Med’s objectives;
• Identifies…