Quality Technical Leader- Medical Device - Maumelle, AR

Quality Technical Leader- Medical Device

Location: Maumelle, AR Position Type: Contract – 1 year

Work Status: US Citizen/Green Card/GC-EAD

Rate: DOE (W2 Only)

Initial feedback is that several candidates are at management level. This position is not management and involves being the individual to write and execute protocols.

General Expectations and Accountabilities:

• Development of the Risk Management files which includes Product Hazard list, Design FMEA, Use FMEA & Process FMEA.
• Development of Quality Function Deployment documentation.
• Ensure that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position.
• Manage self and/or team in accordance with the expected behaviors of the Leadership Qualities.
• Provides technical leadership in solving more challenging technical problems related to quality issues and technologies.
• Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices.
• Solves highly technical complex problems, provides expertise in related specific field of knowledge and consults on complex issues and projects.
• Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert.

Position Specific Accountabilities: (Modify to meet specific details of the assignment) Engineering and Leadership For Medical Device New Product Development (90% of time)

• Actively participate in and/or facilitate the development of deliverables required for medical device product development.
• Actively participate in the development of product development plans, specifically components that focus on design reviews, quality plans, design transfer, and design verification/validation.
• Direct all activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety and performance.
• Ensure new products meet customer requirements and specifications.
• Lead and ensure compliance to all risk management requirements.
• Partner within cross functional teams to determine root cause and mitigations of product issues as they arise during development.
• Where appropriate, implement Design of Experiments and Problem Analysis/Solving concepts in conjunction with R&E.
• Actively participate in the development of statistical plans and rationale for design control activities/requirements.
• Actively partner with the project teams to facilitate the incorporation of all quality system elements, root cause analysis, corrective action and continuous improvement principles throughout the entire product redesign.
• Support and facilitate updates to the Design History File.
• Where appropriate, incorporate the concepts of Lean Six Sigma to solve product /process nonconformance issues.

Deliverables, Responsible for Developing:

• Risk Management files
• Quality Functional Deployment for Design Transfer
• Validation Acceptance Criteria
• Release of Investigational Product for Clinical Evaluations
• Design History File
• Initial Release and Revisions to Design/ Input Forms
• New Supplier Qualifications

Deliverables, Review and Approval:

• Design Reviews Plans
• All Design Verification and Validation Protocols and Reports
• All Design Verification Testing Specifications
• All Process Validation Protocol and Reports (IQ, OQ, and PQ)
• Regulatory Strategy Plan
• Manufacturing Strategy Plan
• Device History Records
• Design Transfer Plan
• Supplier Approval Plan
• Annual Post Market Review

Systems Compliance (10% of time):

• Ensure new product development is in compliance with medical device regulations and internal procedures.
• Implement the Root Cause Analysis concepts to investigate issues requiring Corrective and Preventative Actions.
• Lead, participate in and/or facilitate in monthly complaint review meetings (as needed).
• Review, approve and be actively involved in the maintenance and updates to design history and risk management files.
• Participate in internal and external audits as needed.
• Maintain personal compliance to all internal systems as required, such as training.

A validation engineer – This person will be expected to develop/design, gain alignment on approach and complete validations (including writing & executing protocols, writing protocol reports and deviations) in multiple areas. They will need to interface with engineering, quality and operations personnel in multiple areas (Solution Mix and water systems, converting processes, basesheet processes (nonwovens type material) and lab. This person must have experience with cosmetic and/or medical device validations. Open to candidates with less than 10 years of experience if they have a solid background.