Quality Engineer III

Join a growing medical device manufacturing organization as a senior-level Quality Engineer, leading quality systems, validation activities, risk management initiatives, and continuous improvement projects. This position offers significant ownership across product development, process validation, customer quality interactions, and regulatory compliance efforts.

Client Details

Our client is a rapidly expanding advanced manufacturing organization that develops highly engineered products used in critical healthcare applications. Known for innovation, technical excellence, and investment in employee growth, they offer an environment where engineers can make a tangible impact on product quality and manufacturing performance.

Description

• Lead quality engineering activities supporting new product introduction, process development, and manufacturing improvements.
• Drive risk management initiatives utilizing tools such as PFMEA and other risk mitigation methodologies.
• Lead root cause investigations and implement effective corrective and preventive actions (CAPA).
• Develop, execute, and support process, equipment, and product validation activities.
• Establish and maintain quality control plans, process controls, and statistical monitoring systems.
• Ensure compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulatory requirements.
• Participate in and lead technical and design reviews throughout the product lifecycle.
• Serve as the quality lead on product development, sustaining engineering, and continuous improvement projects.
• Partner directly with customers to resolve quality concerns and complaints.
• Generate and manage process deviations, change notifications, validation protocols, and validation reports.
• Support troubleshooting and optimization of manufacturing processes.
• Develop and maintain metrology systems and measurement methodologies.
• Conduct Gage R&R studies and data-driven quality assessments.
• Review and approve nonconformance dispositions.
• Analyze manufacturing and validation data to identify opportunities for improvement.
• Create quality procedures and deliver training across the organization.
• Support calibration and maintenance programs to ensure equipment compliance.
• Mentor team members and serve as a subject matter expert across multiple quality disciplines.

Profile

• Bachelor's degree in Engineering or a related technical discipline.
• Experience in Quality Engineering within a medical device manufacturing environment.
• Working knowledge of ISO 13485 and FDA 21 CFR 820 requirements.
• Experience supporting quality systems, validations, and regulatory compliance activities.
• Strong technical writing and documentation skills.
• Experience utilizing statistical analysis tools, including Minitab or equivalent software.
• Proven problem-solving skills with experience in root cause investigations and CAPA.
• Ability to communicate effectively with customers, suppliers, and cross-functional teams.
• Experience driving process improvements within a regulated manufacturing environment.
• Ability to independently manage projects and prioritize multiple initiatives.

Job Offer

• Salary range of $65,000 to $102,000.
• Opportunity to lead quality initiatives in a highly regulated and innovative industry.
• Visible role with direct impact on product quality, compliance, and customer satisfaction.
• Exposure to advanced manufacturing technologies and complex engineering challenges.
• Strong career development potential within a rapidly growing organization.
• Collaborative culture that values technical expertise, continuous learning, and innovation.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.