Quality Engineer 2 Medical Divice

Our Global medical device client is seeking a Staff Quality Eng 2 in a hybrid role reporting to the Sr Manager of Quality Engineering in the design center.

Relo available for the right candidate - no sponsorship

In this role you will be responsible for the Wearable Injector platform will serve as a core team member, and is responsible for combining design control expertise, creative problem-solving approaches and strong analytical skills to support new product development and product maintenance using quality engineering skills including but not limited to process validation, measurement system analysis, root cause analysis and design verification.

The position requires the ability to handle multiple projects, from product inception through product launch and maintenance. In addition, this position will play an active role in the processes to ensure products meet quality standards consistent with both corporate and unit policies, while meeting all design control and other regulatory requirements.

Main Responsibilities:

• Evaluation of customer requirements to identify applicable quality standards
• Serve as core team member
• Release product during development activities
• Realization of quality functional reviews
• Ensure implementation of PS global procedures and standards for QE engineering activities
• Provide support to internal, regulatory body and customer audits and associated corrective actions
• Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
• Consistent application of technical principles, theories, concepts and quality sciences / tools
• Reviews and has Quality Engineering approval authority for new and modified design / process specifications including product performance specifications, test methods, etc.
• Contributes to the completion of specific programs and projects
• Ensures quality conduct of projects, including design, data summary and interpretation and report generation for self and developers
• Independently determines and develops approach to solution
• May provide guidance and work direction to other team members
• Designs and performs development working independently within defined parameters with minimal supervision required
• Liaise with Manufacturing Plants
• Provide functional support to cross-functional teams
• Define product control strategy
• Lead risk management activities
• Ensure design control elements are satisfied
• Ensure/ perform process validation activities
• Develop/ perform supplier qualification plans have been defined and completed
• Evaluate test methods used in project activities
• Develop systems, processes, and procedures related to project quality activities
• Supports continuous improvement of current products and practices to improve quality, customer experience, and worldwide market share
• Ensuring the terms on the agreement are met
• Support customer facing teams by providing technical support from a quality perspective
• Share risk mitigation strategies and control plans for the device with the customers as applicable
  

RequirementsEducation: BS degree in Engineering, or other scientific field

Experience: Quality Engineering experience or 12+ years of industry experience (Medical Device/ Pharmaceutical)

Special Skills:

• Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
• Knowledge of design control principles
• Thorough understanding of statistical methods for Quality Assurance
• Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management
• Knowledge and experience in manufacturing, project management and engineering
• Good written and oral communication skills
• Excellent problem solving and analytical skills
• Must possess excellent oral and written communication skills, and supervisory/leadership capability
• Ability to handle multiple projects simultaneously in an unsupervised environment