We're seeking a Senior Quality Engineer to drive quality systems excellence, support manufacturing operations, and lead continuous improvement initiatives within a regulated medical manufacturing environment. This role offers ownership of key quality processes including QMS compliance, risk management, validation activities, customer quality support, and process optimization.
Client Details
Our client is a growing advanced manufacturing organization known for delivering highly engineered products used in demanding and regulated industries. The company offers a collaborative environment where quality and innovation are central to business success, creating strong opportunities for professional growth and impact.
Description
- Support and enhance the Quality Management System (QMS) to ensure ongoing compliance and effectiveness
- Partner with leadership and cross-functional teams to maintain ISO 13485 compliance standards
- Mentor and train Quality Engineers while supporting onboarding and professional development
- Lead root cause investigations and provide hands-on manufacturing support to improve production performance
- Own FMEA activities and risk management processes across products and manufacturing operations
- Manage customer complaints, RMAs, and customer-facing quality issues
- Support equipment qualification and validation efforts including IQ, OQ, and PQ protocols
- Conduct Measurement System Analysis (MSA) and Gage R&R studies
- Implement new inspection technologies and quality control methodologies
- Lead continuous improvement projects through statistical analysis and data-driven decision making
- Manage change control processes and associated risk assessments
- Support supplier quality programs, evaluations, and approved supplier management
- Develop and revise SOPs, work instructions, and quality documentation
- Perform product inspections and quality reviews as needed
Profile
- Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical field
- 5-10 years of quality engineering experience within medical device or medical component manufacturing
- Strong understanding of Quality Management Systems and ISO 13485 requirements
- Experience with CAPA, nonconformance management, calibration, and root cause analysis
- Hands-on knowledge of FMEA and risk management methodologies
- Experience with validation protocols including IQ, OQ, and PQ
- Proficiency with metrology equipment including vision systems, microscopes, profilometers, and precision measurement tools
- Ability to interpret technical drawings, blueprints, and GD&T
- Strong statistical analysis skills with experience using Minitab or similar software
- Experience supporting FDA, customer, or registrar audits is highly desirable
- Advanced Microsoft Office skills, including Excel and data analysis capabilities
- Portuguese language skills are a plus
Job Offer
- Salary of $110,000 to $130,000.
- Join a stable and growing organization serving regulated, high-tech industries
- Make a direct impact on product quality, compliance, and operational excellence
- Gain exposure to advanced manufacturing technologies and processes
- Work closely with executive leadership and cross-functional engineering teams
- Enjoy a role with significant ownership, autonomy, and career advancement potential
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.