Quality Engineer - Combination Products

Staff Quality Engineer – Combination Products

BD (Tissuemed Ltd) – Tempe, AZ

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.

• Technical leadership skills including an understanding of medical device operations (e.g., manufacturing, process development, quality assurance) and chemical and pharmaceutical operations (e.g., drug product manufacturing, analytical testing, process development and quality assurance)
• Ability to create, support, review, and investigate analytical test methods used to support pharmaceutical combination devices
• Create, support, and review chemistry, manufacturing, and controls device submissions
• Participate as team leader or active member to meet company objectives and ensure department responsibilities are completed
• Lead development of risk assessments and test method activities (e.g., development and validation of physical and analytical test methods)
• Lead component qualifications, design validation, design verification, drug stability and process validation
• Lead product investigations
• Make and present risk‑based decisions
• Assess product changes against product design
• Support translation of design inputs into manufacturing control plans
• Develop and implement procedures to comply with corporate and industry standards
• Coordinate and/or direct all aspects of product development activity related to a product line
• Represent quality engineering 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
• Comply with company procedures and policies, government regulations
• Actively participate in training and provide input to training employees on division procedures and policies
• Travel for business, project, and issues up to 25% of time
• Other duties and projects, as assigned

• 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 engineering or quality engineering experience within the medical device, pharmaceutical, or equivalent industry
• Pharmaceutical or combination product experience preferred

• Understanding of product use and impact on user(s) to manage risk effectively
• Apply quality engineering tools (Sampling Plans, Root Cause Analysis, Statistics, etc.)
• Lead creation of risk management files
• 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, and prototyping experience
• Create and provide training
• 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

• Quality Engineering Certification (ASQ) or equivalent

The employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The employee frequently is required to verbally communicate with other associates. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch.

A fast-paced, team-oriented open cubicle environment.

Travel required:

≤25%

BD is one of the largest global medical technology companies. Advancing the world of health™ is our purpose, and it’s no small feat. We value the human element across our global teams and provide an environment where you are supported to learn, grow, and become your best self. Join us and help reinvent the future of health. You will be part of a culture that celebrates accountability, continuous improvement, and diversity.

BD is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectionate or sexual orientation, gender identity or expression, genetics, disability, military eligibility, or veteran status, and other legally protected characteristics.