Senior Design Quality Engineer

Position Overview:

As a key member of the Quality Team, the incumbent will support quality activities related to the design, development, and reliability. The Senior Design Quality Engineer ensures that compliance to customer, risk management, quality, and Design Control requirements is demonstrated and helps to ensure successful transfer of the design to manufacturing. They are responsible for accurate and independent generation and evaluation of Design History File documentation and overall Quality System compliance.

Essential Job Functions and Responsibilities

• Provide technical and statistical reliability support to Product Development, Manufacturing and Quality organizations
• Assist with major efforts, or phases of projects, to resolve advanced and complex technical and Quality-related problems
• Contribute to New Product Introduction Projects as a core team member and communicate activities to the extended team members of Quality
• Support transfer activities by developing and executing the transfer validation strategy.
• Support the product development teams in the adoption and use of best practices, Quality tools, and Design Control methodologies
• Leads root cause investigation using Lean Principles and Tools
• Perform Risk Analysis including Fault Tree Analysis (FTA), Human Factors/Usability, and Failure Mode and Effects Analysis (FMEA) activities to ensure risks are identified and appropriately addressed
• Monitor and develop reliability improvements to existing & new designs
• Support Post Market Surveillance in the investigation of product complaints to determine the root cause and recommend appropriate corrective and preventive action to prevent recurrence
• Support supplier development and continuous improvements; monitoring supplier performance, KPI's, implementing corrections, and audits (if required).
• Support verifications/validations either at Outset or with external vendors for cost, quality, and capacity initiatives.
• Report on achievement of targets and identify any actions required.
• Work with other Groups to maintain an approved internal Quality System that meets the requirements of GMP's, QSR 21 CFR Part 820 and ISO 13485
• Evaluate quality data and prepare regular reports to monitor trends.
• Generate, review, and approve Engineering and Development Change Orders
• Support internal and external audits
• Support additional activities, as assigned

Required Qualifications

• Bachelor's degree in Engineering or Science (or similar) is required. Master's degree is preferred.
• Minimum of 7 years of hands-on experience in the Quality Engineering discipline.
• Prior experiences in the medical device field is required; preferably experience with Capital Equipment and single use medical devices.
• Knowledge of FDA Quality System requirements, ISO Quality System) requirements, ISO Risk Management) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.
• Must be able to communicate fluently in both written and spoken English

Desired Qualifications

• Ability to work effectively in a fast paced and dynamic environment.
• A self-starter, motivated and able to positively motivate others.
• Focused, target driven with a positive, can-do attitude.
• Drive to assigned objectives which delivers best practice results, added value and continuous improvements across the business and quality management system.
• Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers.
• Strong written and verbal communication skills.
• Certified Quality Engineer a plus.
• Lead Auditor certification a plus.
• Lean Certification a plus.
• Experience with statistical analysis software a plus.