Job Description

*W2 only no C2C*

Sr. Quality Engineer (Through end of February 2026 // Jacksonville, FL):

Expected traditional inside office work setup (5days)

Education Required: Bachelors’ degree in Engineering

Years’ Experience Required: Minimum 4+ years. But preferring candidates with 5 – 15+ years of experience with Risk Management (including P1 and P2 calculations), Validation, and Qualification activities.

Duties:

• Provide Quality Engineering support to multiple projects, including supplier quality engineering support.
• Day to day Risk Management review is anticipated. Strong Risk Management experience is a must.
• Develop, execute, analyze, and report on validations/qualifications activities including but not least: IQ, OQ, PQ, MVP, Test Method Validations to support commercial release product lines.
• Evaluate, review and/or update multiple quality records, including but not limited to: Design files, Process documents, and Risk Management files to be following ISO standards and local procedures.
• Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities, with multiple functions, internal and external, to provide quality engineering and supplier quality engineering support to assure requirements meet project expectation and meet local procedures and regulations.
• Prepares reports and/or necessary documentation in the project scope, and provides to applicable stakeholders, both internal and external on scheduled expected time.
• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment when require.
• Specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to products or materials to meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.
• Will support multiple projects including, but not limited to areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as required.
• Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6 M, Ishikawa Diagram, Pareto Charts) when require.
• Interface and interact with cross functional team in Production, Manufacturing/Process Engineering, R&D, Regulatory department and other to resolve process issues and implement changes.
• Apply knowledge of process control tools, statistical sampling, and other analytical techniques on the qualification activities to maximize the quality and flow of product through the production line.
• Identify, analyze, and manage risk through product life cycle with use of risk management tools.

Must Have Experience:

• Bachelors’ degree in Engineering, Science or Technical field.
• Minimum of 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality.
• Strong Experience with Test Method Validation and MSAs.
• Strong Risk Management Experience (Experience in Risk Documentation: Write, review, approve multiple quality records includes but not limited to: Design Files, Risk Management files, RPM P1 and P2 calculations, Risk Mitigations, etc.)
• Experience in Validation/Qualification activities: Write, coordinate, execute, create reports, IQ, OQ, PQ, MVPR, etc.
• Sampling size determination: For Attribute or variable data
• Strong statistical background
• Able to work with minimum of supervision in a hybrid working organization set up
• Good writing and documentation skills.
• Good organizational and verbal communication skills.
• Ability to work in fast-track schedule and meet deliveries on time.

Preferred Experience:

• ASQ Quality Engineer Certification.
• Bilingual English/Spanish preferred but not required.
• Previous Medical Device experience is helpful.
• Lean / Six Sigma Certification
• Manufacturing experience within a controlled and regulated industry

Job Tags

Similar Jobs