Job Description

Job Title: Senior Quality Engineer

Location: Jacksonville, Florida

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Work Setup: Primarily onsite (5 days/week) with potential for hybrid (3 days onsite)

Position Summary:

We are seeking an experienced Senior Quality Engineer to support multiple projects within the medical device sector. This individual will play a key role in ensuring product and process quality, regulatory compliance, and risk management across various product lines. The ideal candidate will have a strong foundation in validation, risk documentation, and statistical analysis, and will be capable of working independently in a hybrid organization.

Key Responsibilities:

• Lead and support validation and qualification activities, including IQ, OQ, PQ, MVP, and Test Method Validations.
• Provide risk management support: prepare, review, and approve risk documentation (Risk Files, RPM P1 and P2 calculations, mitigations).
• Determine appropriate sample sizes for attribute and variable data based on statistical analysis.
• Provide day-to-day quality engineering support for multiple projects, including supplier quality activities.
• Review and update quality records such as Design Files, Process Documentation, and Risk Management Files to align with ISO standards and internal procedures.
• Participate in root cause analysis using tools such as 5 Whys, Ishikawa Diagrams, and Pareto Charts.
• Support the implementation of inspection, testing, and statistical methodologies to improve process control and product quality.
• Interface with cross-functional teams across Production, R&D, Regulatory, Manufacturing, and Quality to ensure project success and timely deliverables.
• Interpret and apply regulatory, industry, and internal standards and policies to support compliance.
• Prepare documentation and communicate project status to stakeholders in a timely manner.
• Contribute to the development and execution of quality systems, processes, and initiatives to enhance overall product reliability and performance.

Required Qualifications:

• Education: Bachelor's degree in an engineering discipline.
• OR an advanced degree in engineering with reduced experience requirement.
• Experience:
• Minimum 4+ years of experience in the medical device industry in Engineering, Quality, or Supplier Quality.
• OR 2+ years with an advanced degree and proven hands-on experience.
• Strong background in validation/qualification , including writing and executing protocols and reports (IQ, OQ, PQ, MVP).
• Proficient in Risk Management documentation and practices (Risk Files, RPM P1/P2, mitigations).
• Expertise in Test Method Validation and Measurement System Analysis (MSA) .
• Excellent statistical and data analysis skills.
• Strong communication, documentation, and organizational skills.
• Ability to work with minimal supervision in a fast-paced, diverse team environment while upholding ethical standards.
• Demonstrated commitment to Medtronic’s Core Values .

Preferred Qualifications (Nice to Have):

• ASQ Certified Quality Engineer (CQE).
• Bilingual (English/Spanish) preferred.
• Prior experience working with Medtronic or other medical device manufacturers.
• Six Sigma / DMAIC certification (Lean or Black Belt).
• Experience in regulated manufacturing environments (FDA, ISO 13485, etc.).

Additional Information:

• The position supports multiple high-priority projects, with significant activity expected to ramp up soon.
• Interviews are expected to be scheduled within two weeks of receiving applications.
• The candidate will support various product lines and project phases, including design, production, quality inspection, and supplier collaboration.

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