Senior Quality Engineer - Product Development

Job Summary

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.

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

Job Responsibilities

• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance)
• Leads development of risk assessments and test methods
• Leads component qualifications, design validation / verification and process validation
• Leads product investigations
• 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
• Quality engineering representation on Product Development Teams to design, develop, and implement new products and processes for a medical device, translating intangible design inputs into tangible engineering specifications and test plans
• Quality engineering representation on 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
• Comply with company procedures and policies, government regulations
• Ability to travel for business, project, and issues approximately up to 25% of time.
• Other duties and projects, as assigned

Education and Experience

• BS in Engineering
• Minimum of five years' experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
• Pharmaceutical or combination product experience preferred

Knowledge and Skills

• Knows how products are used and impact the user(s) so that risk can be managed effectively
• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• A bility to lead creation of risk management files
• Ability to develop solutions with business impact
• A dvanced statistical and risk assessment techniques
• Working knowledge of test method (development and validation), equipment qualifications, process and design validation, risk assessment techniques, and component qualification methodologies
• 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 trainin
• 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 including ISO 13485, ISO 14971, 21 CFR 210/211/820
• Preferred Qualifications:
• Quality Engineering Certification (ASQ) or equivalent