Engr , Quality

Quality Engineer

This position supports process management for existing legacy products and risk management. This position is part of the R&D Product Engineering Team (MDR Project) whose responsibility is to support the EU MDR project timeline, including product remediation testing and label changes.

Responsibilities:

• Leads development of risk assessments and test methods
• Supports component qualifications, design validation / verification and process validation
• Ability to make and present risk-based decisions
• Assess process changes against process risk documents
• Supports translation of design inputs into manufacturing control plans
• Participate and provide input to training on department/division procedures, and policies
• Participate in project planning, budgeting, scheduling and tracking
• Develop and implement procedures to comply with corporate and industry standards
• Provide positive example and actively promote compliance to division, corporate and industry standards
• Maintain a professional working relationship with internal and external customer and support staff
• Prepare and present project updates and technical discussions
• Working knowledge of product use to manage user(s) impact with the ability to manage risk effectively
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Working knowledge in some of the related business technologies
• Advanced statistical and risk assessment techniques
• Working knowledge of test method (development and validation), equipment qualifications, and design validation, risk assessment techniques, and component qualification methodologies
• Ability to write protocols for Gage R&R/ MSA studies, perform those studies and analyze results preferably using Minitab
• Working knowledge of blueprints, and GD&T
• Working knowledge of code level review, software logic review, black box testing, and system validation
• Ability to make and present risk-based decisions
• Strong interpersonal skills
• Ability to analyze and optimize manufacturing and quality systems
• Product, design & prototyping
• Ability to create and provide training
• Software application skills
• Problem solving ability
• Ability to create, review and coordinate test protocols and reports
• Ability to generate engineering proposals
• Oral and written presentation skills
• Ability to Lead cross functional teams
• Understanding of regulatory requirements
• Ability to create and/or update process mode failure effects analysis (pFMEA) and other related risk documents

Required Qualifications:

• Strong interpersonal skills
• Ability to analyze and optimize manufacturing and quality systems
• Product, design & prototyping
• Ability to create and provide training
• Software application skills
• Problem solving ability
• Ability to create, review and coordinate test protocols and reports
• Ability to generate engineering proposals
• Oral and written presentation skills
• Ability to lead cross functional teams
• Understanding of regulatory requirements
• Ability to create and/or update process mode failure effects analysis (pFMEA) and other related risk documents
• Education and/or
  
  Experience:
  
  At least 3-5 years of engineering or Quality engineering experience within the medical device or equivalent industry. Lean or Six Sigma Certified (Green or Black Belt) preferred.