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.