Process Quality Engineer (Onsite in Latham, New York)

About the role

The Process Quality Engineer at Latham ensures facility and product compliance with ISO 13485 and all relevant regulations, standards, and procedures. They also verify products meet requirements before distribution and lead ongoing quality and process improvements.

Responsibilities

• Works closely with Area Managers, Team/Group Leads and Manufacturing Engineers (MEs) to optimize production within an area by creating and executing accurate and effective documentation compliant with GDP, documenting and tracking nonconformances, supporting problem-solving and continuous improvement activities, and maintaining documentation verifying effective On the Job Training (OJT) of operators.
• Ensures that executed processes meet the requirements of the site’s QMS, including but not limited to: the creation of Quality Data Sheets (Data Collects), change control, deviations, nonconformances, PFMEAs/control plans, Device History Records (DHRs) and Corrective and Preventive Actions (CAPAs).

Requirements

• 2+ years of related Quality Engineering experience in the medical device industry preferred, or other regulated industries required (aerospace, defense, automotive, etc.).
• Strong experience with and understanding of ISO 13485 preferred.
• Strong process and manufacturing equipment validation experience, PFMEA’s, control plans, and working with statistical analyses tools.
• Strong ability to support Nonconformances, CAPA’s, process documentation, Measurement System Analysis, Test Method Validations, and Design History Review, among other things is required.
• A bachelor’s degree or higher in Mechanical Engineering, Electronics Engineering, Science or equivalent.
• Lifetime Lean Six Sigma certification preferred but not required.

Qualifications

• Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• Excellent communicator with an ability to work well cross functionally, and adapt to changing priorities.
• Requires up to 10% travel as required by business needs.

Skills

• Strong process and manufacturing equipment validation experience.
• PFMEA’s, control plans, and working with statistical analyses tools.
• Support Nonconformances, CAPA’s, process documentation, Measurement System Analysis, Test Method Validations, and Design History Review, among other things.

Benefits

Details about our benefits can be found here.

Pay

The pay range for this position in Latham, NY is $87,000 to $139,200. The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

Schedule

This position requires the employee to be onsite five days per week.