Senior Quality Engineer

The Senior Quality Engineer leads quality assurance processes, mentors quality staff, and ensures compliance with FDA (CFR 820) and ISO 13485 standards through ownership of CAPAs, complaints, and continuous improvement initiatives. This role involves cross-functional collaboration, supervision of quality personnel, and driving quality system enhancements to meet customer and regulatory requirements.

Client Details

This company is a leading provider of precision manufacturing solutions, specializing in complex machining, injection molding, and additive manufacturing for highly regulated industries such as medical, aerospace, and semiconductor. With multiple facilities across the U.S., it delivers high-quality, custom-engineered components while maintaining strict compliance with industry standards and certifications.

Description

As a Senior Quality Engineer:

• Act as the Voice of the Customer (VOC) and lead quality assurance efforts across projects.

• Mentor and train Quality Engineers and Technicians on quality tools, methodologies, and regulatory compliance.

• Own and manage CAPA, SCAR, and complaint investigations with full documentation in compliance with FDA and ISO 13485.

• Develop, execute, and improve quality processes, including control plans, FMEAs, capability studies, and inspection methodologies.

• Supervise quality personnel, including performance reviews, hiring, training, and conflict resolution.

• Ensure proper document control, including both digital and physical records for quality management systems.

• Support audits and inspections by customers, regulatory bodies, and internal stakeholders.

• Lead management reviews and drive continuous improvement initiatives across quality and production systems.

Profile

A successful candidate for this Senior Quality Engineer role will have:

• A Bachelor's degree in Engineering, Quality, or a related technical field.

• At least 5 years of experience in quality engineering within a regulated manufacturing environment (e.g., medical device, aerospace).

• Strong knowledge of FDA (CFR 820) and ISO 13485 compliance, along with hands-on experience managing CAPAs, SCARs, and complaints.

• Proficiency in quality tools such as FMEA, control plans, capability studies, GD&T, and statistical analysis.

• Proven ability to lead, mentor, and collaborate cross-functionally, while effectively managing documentation and driving continuous improvement.

Job Offer

Here's what's on offer for a candidate in this role:

• Comprehensive benefits package including medical, dental, vision, life insurance, and disability coverage.

• Opportunities for career growth and advancement within a growing, innovation-driven manufacturing environment.

• A chance to work on high-impact projects in regulated industries like medical and aerospace, using advanced technologies and processes.

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.