Quality Engineer | Medical Device Manufacturing | IQ/OQ/PQ Validation | Direct Hire

Quality Engineer | Medical Device Manufacturing | IQ/OQ/PQ Validation

Drive quality, improve processes, and help ensure products meet the highest standards.

We are seeking an experienced Quality Engineer to support quality, manufacturing, and product development activities within a regulated manufacturing environment.

This position will work closely with Operations, Engineering, and cross-functional teams to improve manufacturing processes, reduce scrap, investigate quality issues, identify root causes, implement corrective actions, and reduce customer complaints.

A major focus of this position is manufacturing process validation, including the development, execution, and documentation of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

The ideal candidate combines strong manufacturing quality experience with statistical analysis, problem-solving, process validation, CAPA, and continuous improvement skills.

What You'll DoProcess Validation & Manufacturing Quality

• Plan, develop, execute, and document manufacturing process validations
• Manage IQ, OQ, and PQ validation activities in accordance with Quality Management System requirements
• Evaluate manufacturing processes and identify opportunities to improve quality, consistency, and efficiency
• Develop inspection plans, test methods, specifications, and Standard Operating Procedures (SOPs)
• Review internal quality issues and determine appropriate material dispositions
• Analyze equipment and manufacturing test results
• Support manufacturing and process changes through appropriate validation activities
• Assist with discrepant and nonconforming material disposition

Quality Engineering & Problem Solving

• Investigate internal and external quality concerns
• Perform root cause analysis and support corrective and preventive actions (CAPA)
• Analyze scrap, defects, customer complaints, and manufacturing quality trends
• Identify and implement corrective actions to prevent recurring quality issues
• Review supplier and material nonconformance reports and provide dispositions
• Support customer investigations and communication regarding product quality concerns
• Partner with Operations and Engineering on process development, cost reduction, and quality improvement initiatives

Statistical Analysis & Process Control

• Collect, analyze, and trend manufacturing quality data
• Utilize Statistical Process Control (SPC) and statistical methods to evaluate process performance
• Perform process capability analysis
• Conduct sample-size determination and statistical evaluations
• Perform hypothesis testing and normal distribution analysis
• Identify meaningful trends and communicate findings to leadership and cross-functional teams

Design Quality & Risk Management

• Serve as a Quality representative for New Product Development and product/process changes
• Participate in design control activities throughout the product lifecycle
• Support process control and product specification development
• Participate in product and process risk-management activities
• Support risk-management activities in accordance with ISO 14971
• Assist with product design verification and validation testing when required

Quality Systems & Compliance

• Support internal and external audits
• Assist with audit requests, observations, and nonconformances
• Maintain accurate quality and validation documentation
• Develop and review technical specifications, manufacturing documentation, and scientific test results
• Ensure quality activities comply with established Quality Management System requirements

What We're Looking For Required Qualifications

• Bachelor of Science degree in Engineering
• Demonstrated experience developing, authoring, executing, and managing IQ/OQ/PQ manufacturing process validations
• Strong understanding of manufacturing quality and process controls
• Experience with Corrective and Preventive Action (CAPA)
• Strong knowledge of Statistical Process Control (SPC)
• Experience performing root cause analysis and corrective actions
• Strong statistical and data-analysis skills
• Ability to interpret engineering drawings, specifications, and blueprints
• Experience using precision inspection and measurement equipment such as calipers and micrometers
• Strong technical writing and documentation skills
• Excellent problem-solving and decision-making abilities
• Ability to independently prioritize and manage multiple projects

Highly Preferred

• 2 years of medical device manufacturing or development experience
• Knowledge of ISO 14971 and risk management
• Experience supporting design controls and New Product Development
• Medical device Quality Management System experience
• Experience with product/process verification and validation
• Lean Manufacturing and/or Six Sigma experience
• Experience using tensile testing equipment such as Instron

What Makes You Successful

You'll thrive in this position if you:

• Enjoy investigating complex quality and manufacturing problems
• Can take an issue from data analysis through root cause and corrective action
• Understand how validation, quality systems, and manufacturing operations work together
• Are highly detail-oriented without losing sight of production and customer needs
• Communicate effectively with Engineering, Operations, Quality, suppliers, and customers
• Are comfortable working independently and taking ownership of projects
• Bring a continuous improvement mindset to manufacturing quality

Work Environment

This position operates within a manufacturing and distribution environment and requires regular interaction with production operations.

The environment may include moderate to loud noise, varying temperatures and humidity levels, manufacturing equipment, and areas requiring personal protective equipment.

Apply Today

If you're a Quality Engineer with hands-on IQ/OQ/PQ process validation experience who enjoys using data, engineering principles, and structured problem-solving to improve manufacturing quality, we'd like to hear from you.

Apply today to learn more about this opportunity.

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Pay: $60,000.00 - $75,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• This position requires a criminal background check covering your history from age 18 to the present, as permitted by applicable law. Do you have any felony convictions, misdemeanor convictions, or pending criminal charges that you'd like to disclose before we move forward?
• Do you have a valid driver's license?
• How many years of experience do you have developing and executing IQ, OQ, and PQ process validations?
• Do you have professional experience working within medical device manufacturing or development?

Work Location: In person

Salary : $60,000 - $75,000