Senior Quality Engineer - Medical Device - Hialeah, FL

Job Description

Job Description

This Senior Quality Engineer position provides hands-on quality engineering support across product development, supplier quality, manufacturing, and post-market activities. The role is serving as a key quality partner to R&D and operations teams, helping strengthen the QMS, ensure regulatory compliance, investigate product issues, and drive continuous improvement initiatives.

Client Details

This growing medical device company is developing innovative Class II technologies designed to improve outcomes and enhance the experience for both patients and healthcare providers. Operating in a fast-paced startup environment, the organization has recently achieved multiple product approvals and is expanding its portfolio through a combination of internal design expertise and outsourced manufacturing partnerships.

Description

In this role you will report directly into the VP of Quality and be responsible for:

• Supporting new product development activities and maintaining compliance with design control requirements.
• Providing hands-on quality engineering support for process development, manufacturing transfers, validations, and product or process changes.
• Managing risk management activities in accordance with ISO 14971, including hazard analyses and risk assessments.
• Reviewing engineering changes and evaluating quality, validation, and risk impacts.
• Developing, executing, and reviewing process validations, test method validations, and related documentation.
• Utilizing statistical tools and software to analyze process capability, complaint trends, nonconformances, and quality metrics.
• Leading investigations into product failures, deviations, supplier issues, nonconformances, and CAPAs while driving effective corrective actions.
• Supporting complaint handling, failure analysis, post-market surveillance, and regulatory reporting activities.
• Qualifying, monitoring, auditing, and improving supplier performance while maintaining approved supplier records.
• Partnering with manufacturing, engineering, and supply chain teams to improve product quality, process capability, and operational performance.
• Reviewing supplier quality documentation, change notifications, validation records, and corrective action responses.
• Participating in internal audits, supplier audits, regulatory inspections, and audit readiness activities.
• Maintaining and improving quality procedures, work instructions, forms, specifications, and training materials.
• Supporting inspection activities and ensuring inspection methods, acceptance criteria, and sampling plans remain compliant and effective.
• Serving as a key quality resource for the VP of Quality while providing guidance and training across the organization.
• Conducting hands-on product investigations using microscopes, vision systems, and other analytical tools to determine root cause and support issue resolution.
• Collaborating remotely with manufacturing resources at a contract manufacturing site in Central America to address quality and process concerns.

Profile

A successful candidate will have:

• 7+ years of experience within the medical device industry, including 5+ years in Quality Engineering or Quality Assurance.
• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• Strong knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience developing, maintaining, and improving Quality Management Systems (QMS).
• Experience with supplier qualification, supplier audits, supplier performance management, and supplier quality engineering.
• Experience with process validation, test method validation, risk management, CAPA, complaint investigations, and change control.
• Proficiency with statistical analysis tools such as Minitab and quality methodologies including DOE, SPC, and GR&R.
• Ability to thrive in a fast-paced startup environment while balancing compliance, quality, patient safety, and business objectives.

Job Offer

The candidate will receive...

• Competitive salary and potential for salary growth
• Comprehensive benefits package, including health insurance, retirement plans, and vacation/sick leave
• Opportunities for professional development and career advancement
• A positive work environment that values collaboration and innovation
• Work-life balance and flexible scheduling options
• Access to cutting-edge technologies and resources
• Engaging and challenging projects that foster skill development
• Supportive and inclusive company culture
• Networking opportunities within the industry
• Potential for performance-based bonuses or incentives.

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.