Staff Quality Engineer - Product Development - Becton Dickinson

Job Responsibilities

• Technical leadership skills including an understanding of medical device operations (e.g., medical device manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)
• Create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices
• Create, support, review chemistry, manufacturing, and controls device submissions
• Participates as team leader or as an active member of the team to meet company objectives and ensure department responsibilities are completed
• Leads development of risk assessments and test method activities (e.g., development and validation for physical and analytical test methods)
• Leads component qualifications, design validation, design verification, drug stability and process validation
• Leads product investigations
• Makes and presents risked based decisions
• Affirms product changes against product design
• Supports translation of design inputs into manufacturing control plans
• Develops and implements procedures to comply with corporate and industry standards
• Covers 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
• Prepares and presents project updates and technical discussions
• Supports project planning, budgeting, scheduling, and tracking
• Collaborates with internal and external suppliers for audits
• Supports the regulatory department in writing technical submissions
• Complies with company procedures and policies, government regulations
• Participates in training and provides input to training of employees on division procedures and policies
• Other duties and projects, as assigned

Required Education And Experience

• BS in Engineering, Biological Science, or a related engineering field (Masters or Ph.D preferred). Fields of study include Chemical Engineering, Bioengineering, Pharmacy, or Biochemistry
• Minimum of eight years of experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
• Extensive proven understanding of design controls in development stage
• Pharmaceutical or combination product experience

Required Qualifications

• Apply Quality Engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Develop solutions with business impact
• Advanced 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
• Make and present risk-based decisions
• Strong interpersonal skills
• Analyze and optimize manufacturing and quality systems
• Product, design & prototyping
• Problem solving ability
• Create, review and coordinate test protocols and reports
• Generate engineering proposals
• Oral and written presentation skills
• Lead cross functional teams
• Understanding of regulatory requirements including ISO 13485, ISO 14971, 21 CFR 210/211/820 , ICH Guidelines

Preferred Qualifications

• Quality Engineering Certification (ASQ) or equivalent