Sr. Quality Engineer (manufacturing exp req)

Lead Manufacturing Engineer - Process & Quality Systems
Location: Greater Miami Area, FL (near Amelia Earhart Park)
Salary: $120,000-$140,000+ (Negotiable, DOE) + Company-Based Annual Bonus
Excellent Benefits: Medical (100% paid premiums for employees, 80% for family), Dental, Vision, 401k, Life, Disability, HSA, Vacation, Holidays, Sick Time
Job Type: Full-Time; Monday-Friday
Sponsorship is not available

Lead Manufacturing Engineer - Process & Quality Systems Description

Our client is seeking a Lead Manufacturing Engineer to join their team in the Miami area. They are a small, highly capable group that manufactures their own medical devices while also supporting full product design and development. This is a hands-on role centered around quality events and manufacturing process improvement within a collaborative team. You will lead investigations, develop manufacturing and inspection procedures, and play a key role in ensuring consistent, high-quality production. You will spend about 50% of your time supporting quality initiatives, 40% on manufacturing processes, and 10% supporting product development activities. You will also act as a bridge between the Quality team (4) and Manufacturing team (5), supporting cross-functional collaboration and contributing to continuous improvement efforts If you enjoy variety in your day and working across functions rather than staying in a narrowly defined role, this could be a great fit. This opportunity offers the chance to make a meaningful impact and have greater influence within a smaller, agile team. In this environment, your ideas will be heard and put into action, something that can be harder to find in larger organizations. They also offer strong benefits for a company of this size, including 100% employer-paid premiums for employees and 80% for dependents.

Lead Manufacturing Engineer - Process & Quality Systems Responsibilities

Design, develop, and enhance manufacturing processes
Develop inspection methods, lead CAPA and root cause analysis, and ensure compliance
Review engineering drawings for tolerancing, manufacturability, and inspection feasibility
Conduct tolerance stack-up analysis and risk assessments and author FMEAs
Develop work instructions, assembly procedures, and maintain BOMs
Troubleshoot production issues and implement corrective actions and lead IQ/OQ/PQ
Design and implement tooling, fixtures, and test equipment for production and validation
Lead continuous improvement initiatives to improve yield, reduce scrap, and increase efficiency
Support product development while ensuring compliance with design control requirements
Develop and execute design verification and validation protocols
Support audits, manage documentation, and design CAD models and tooling in SolidWorks

Lead Manufacturing Engineer - Process & Quality Systems Qualifications

Bachelor’s degree in engineering
Experience working within a highly regulated environment
Strong experience leading investigations, including CAPA, NCRs, and root cause analysis
Experience developing manufacturing and inspection procedures
Exposure to validation activities (IQ/OQ/PQ), including equipment or process validation
Able to work onsite each day required
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