Staff Quality Engineer - Combination Products

This position supports product leadership and risk management of new product development and sustaining activities for combination products. The role may include aspects of manufacturability, scalability, manufacturing transfer and post launch sustainability of combination products.

Requirements

• Technical leadership skills including an understanding of medical device operations and chemical and pharmaceutical operations
• Ability to create, support, review, and investigate analytical test methods
• Ability to create, support, review chemistry, manufacturing, and controls device submissions
• Ability to make and present risked based decisions
• Assess product changes against product design
• Supports translation of design inputs into manufacturing control plans
• Develop and implement procedures to comply with corporate and industry standards
• Coordinates and/or directs all aspects of product development activity related to a product line
• Leads development of risk assessments and test methods
• Quality engineering representation on Product Development and Design Review teams
• Prepare and present project updates and technical discussions
• Participate in project planning, budgeting, scheduling, and tracking
• Support internal and external supplier audits
• Provide support to the regulatory department in writing technical submissions
• Complies with company procedures and policies, government regulations
• Actively participates in training and providing input to training of employees on division procedures and policies
• Ability to travel for business, project, and issues approximately up to 25% of time
• Other duties and projects, as assigned

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance