Senior Quality Engineer - Jacksonville, FL
About The Position
This role supports Quality Engineering activities at the Jacksonville, Florida manufacturing site, with a primary focus on manufacturing operations and quality release processes that ensure materials and products meet established requirements before use in production and distribution. The position partners closely with Manufacturing, Operations, Supplier Quality, and Engineering teams to drive product quality, process effectiveness, and compliance across manufacturing operations. This is an onsite position based in Jacksonville, FL, requiring presence at the manufacturing facility five (5) days per week to support production operations. This role has the potential of up to 20% travel. The Senior Quality Engineer leads quality engineering initiatives that support manufacturing operations, incoming inspection activities, and product release processes. This role is responsible for driving quality improvements, executing quality-focused projects, ensuring compliance with applicable requirements, and partnering cross-functionally to support manufacturing line performance and product quality objectives.
Requirements
- Bachelor's degree and 4+ years of quality engineering, manufacturing quality, or related experience OR Master's degree and 2+ years of quality engineering, manufacturing quality, or related experience OR PhD.
Nice To Haves
- Experience in the medical device industry supporting manufacturing, quality, or regulatory functions.
- Working knowledge of FDA Quality System Regulation (QSR), ISO 13485, ISO 14971, Good Manufacturing Practices (GMP), and other applicable regulatory standards.
- Experience with audit planning, execution, management, complaint handling, and supplier or internal quality audits.
- Experience leading quality improvement, Continuous Improvement, Lean Manufacturing, Six Sigma, CAPA (Corrective and Preventive Action), nonconformance (NCMR), and root cause investigation activities.
- Proficiency in statistical analysis, process capability, and data-driven quality improvement tools, including Minitab, Microsoft Excel, and Power BI.
- Experience with incoming inspection, product release, quality control, and manufacturing quality systems.
- Knowledge of Geometric Dimensioning and Tolerancing (GD&T) and electrical schematics.
- ASQ Certified Quality Engineer (CQE) or comparable quality certification.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Lead quality operations, decision making on daily activities related to quality compliance, it is important to have good knowledge / experience with FDA, ISO 13485, ISO 14971, or other relevant regulatory standards.
- Analyze quality data and performance trends to identify opportunities for process improvement and risk reduction. Use of AI to create data analysis, PBI and Microsoft excel.
- Complaint Handling and manufacturing assessments.
- Lead projects focused on incoming inspection, material acceptance, and quality release processes to support manufacturing operations.
- Partner with Manufacturing, Operations, and Engineering teams to establish, implement, and maintain quality standards and inspection requirements.
- Develop, improve, and sustain quality procedures, controls, and protocols for materials, components, and finished products.
- Analyze quality data and performance trends to identify opportunities for process improvement and risk reduction.
- Design, implement, and evaluate inspection and testing methods to verify product and process conformity.
- Investigate nonconformances and quality issues, determine root cause, and implement corrective and preventive actions.
- Ensure quality documentation, records, and supporting evidence meet regulatory, compliance, and internal quality system requirements.
- Provide technical guidance on quality-related activities and support continuous improvement initiatives across manufacturing lines.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
