Senior Quality Engineer

The Resonetics Senior Quality Engineer coordinates and accomplishes goals by leading projects, performing analysis, or facilitating the efforts of others.

Responsibilities

• Under general supervision performs and coordinates project & quality support assignments.
• Scopes, troubleshoots issues, and develops solutions to increasingly complex problems.
• Contributes to projects with proficiency across most technical dimensions within the functional area; may support cross-business unit/ global initiatives.
• Acts as a technical resource for developing entry engineers and technicians.
• Leads and coordinates the following activities:

·      Sustaining quality engineering (updating procedures, collecting data)

·      NPI quality engineering activities

·      Quality investigations (e.g. NCRs, CAPAs, complaints)

·      Continuous improvement

• Knowledge and coordination of structured problem solving and how to deploy tools to lead a cross-functional team through moderately complex problem resolution.
• May serve as customer quality liaison.
• Ensures compliance with industry standards and Quality System requirements. 
• Provides technical solutions to wide range of difficult, moderately complex problems; applies knowledge and full understanding of area of specialization, principles, and practices within a technical discipline. 
• Independently determines and develops approach to solutions; assesses circumstances and uses analytical and problem-solving skills to identify reasons for errors or inefficiencies.
• Influences a prompt and constructive response of the team when change is encountered or necessary.
• Explores and recommends operational and technical process efficiencies and improvements with an innovative mindset, weighing calculable risks of various factors.
• Focuses on innovative approaches to business unit area processes.
• Enhances relationships with internal and builds external networks that are diverse in level and business unit expertise.
• Regularly interacts with technical business unit leaders and customers; may engage on multi-business unit/ global team initiatives.
• May serve as informal mentor and technical resource for junior engineers and/or technicians.
• Participates on and demonstrates ability to lead moderately complex projects and initiatives, serving as business unit resource, providing insight for area of technical specialization.
• Assure safety and regulatory compliance by consistently reporting failures / issues to manager and partnering in write up of safety concerns. 

Required Qualifications

• Typically requires a minimum of 5 years of related experience with a Bachelor’s degree in technical discipline; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• Complete understanding of engineering tools, processes, methodologies, and systems within business unit specific areas, including demonstrated experience in lean and six sigma concepts and tool application.
• Demonstrated experience with QSR or ISO 13485.
• Demonstrated knowledge and application of Root Cause Analysis tools, Lean/CI Principles, Systems and common tools.
• Excellent written and verbal communication skills
• Excellent organizational, collaboration and presentation skills
• Thorough understanding and consistent application of technical principles, theories, and concepts within the engineering discipline.

Preferred Qualifications

·      Prior experience in the Medical Device Industry and contract manufacturing

Demonstrated experience in Quality Engineering and/or Quality Systems highly desirable