We are seeking a Senior Quality Engineer to support and continuously improve a robust Quality Management System while ensuring compliance with ISO 13485 standards. This role combines hands-on manufacturing support, process improvement leadership, customer quality ownership, and cross-functional collaboration to drive operational excellence.
Client Details
Our client is a highly respected advanced manufacturing organization serving innovative and rapidly evolving regulated industries. The company invests heavily in quality, technology, and continuous improvement, creating an environment where engineers can make a meaningful impact on products that matter.
Description
- Support the effectiveness, maintenance, and continuous improvement of the Quality Management System (QMS).
- Partner with leadership and cross-functional teams to ensure compliance with ISO 13485 requirements.
- Mentor and train Quality Engineers while supporting onboarding and professional development initiatives.
- Provide shop floor quality support, troubleshoot manufacturing issues, and lead root cause investigations.
- Own Risk Management activities, including FMEA development and ongoing risk mitigation efforts.
- Manage customer complaints, returns, and corrective action activities to ensure timely resolution.
- Support equipment qualification and validation activities including IQ, OQ, and PQ protocols.
- Execute Measurement System Analysis (MSA) and Gage R&R studies to improve inspection reliability.
- Identify, implement, and validate new inspection technologies and quality control methods.
- Lead quality improvement projects through statistical analysis and data-driven decision-making.
- Manage engineering change processes and associated risk assessments.
- Support supplier quality activities, including Approved Supplier List evaluations and performance reviews.
- Develop and maintain quality documentation, SOPs, work instructions, and forms.
- Perform product inspections and other quality-related activities as require
Profile
- Bachelor's degree in Engineering, Quality, Manufacturing, or a related technical discipline.
- 5-10 years of quality engineering experience within medical device or medical component manufacturing.
- Strong understanding of ISO 13485 Quality Management Systems and regulatory compliance.
- Experience with CAPA, nonconforming materials, calibration systems, and root cause analysis methodologies.
- Proficiency with metrology equipment, inspection systems, and measurement techniques.
- Ability to interpret engineering drawings, blueprints, and GD&T specifications.
- Experience supporting customer, FDA, or third-party quality audits is highly desirable.
- Strong data analysis skills with statistical software such as Minitab.
- Proficiency with Microsoft Office applications and ERP systems.
Job Offer
- Opportunity to lead quality initiatives in a medical device manufacturing environment.
- Significant influence on operational performance, compliance, and continuous improvement efforts.
- Exposure to advanced manufacturing processes and cutting-edge technologies.
- Collaborative culture with direct interaction across engineering, operations, and leadership teams.
- Strong potential for professional growth, leadership development, and long-term career advancement.
- Comprehensive benefits package.
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.