Quality Engineer II

bdx; Tempe (AZ); On-site; USD 80,000 - 110,000; Full time

Job summary

BD in Tempe, AZ is seeking a Quality Engineer with 2+ years in medical device quality engineering. You will lead risk assessments, design/process validation, and support audits and regulatory submissions.

The role emphasizes cross-functional collaboration with product development, manufacturing, and suppliers to build robust quality systems and ensure ISO 13485/14971 compliance. Travel up to 25% may be required.

Qualifications

• BS in Engineering or equivalent required.
• Minimum of two years’ experience in engineering or quality engineering in medical device/pharma or equivalent.
• Knowledge of ISO 13485 and ISO 14971.
• Ability to travel up to 25% for business.
• Proven ability to develop risk management files and implement QMS processes.

Responsibilities

• Lead risk assessments, test methods, and design validation/verification.
• Direct product development activities for a product line and coordinate audits.
• Prepare and present technical updates and risk-based decisions.
• Support regulatory submissions and external supplier audits.
• Develop and implement procedures to comply with corporate and industry standards.
• Collaborate with manufacturing, design, and QA to optimize quality systems.

Skills

Quality engineering

Risk management

Design validation

Process validation

Regulatory compliance

Cross-functional collaboration

Education

BS in Engineering

Job description

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

Job Responsibilities: Primary Duties, Roles, and/or Authorities

• 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

• Leads development of risk assessments and test methods

• Quality engineering representation on Product Development 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

• 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 two years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry

Knowledge and Skills:

Required Qualifications:

• 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.)

• Ability to lead creation of risk management files

• Ability to 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

• 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

• 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

Preferred Qualifications:

• Quality Engineering Certification (ASQ) or equivalent

• Electrical Engineering degree

Physical Demands:

While performing the duties of this job, 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.

Work Environment:

While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment. BD is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers

Becton, Dickinson, and Company 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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Primary Work Location

USA AZ - Tempe Headquarters