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Senior Quality Engineer

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BD

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Location:
United States , Tempe

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

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Job Description:

This position supports product leadership and risk management of new product development and sustaining activities. Additionally, this position may have direct reports as needed.

Job Responsibility:

  • Technical leadership skills including familiarity with 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
  • Competence in developing and delivering risk-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 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
  • Ability to travel for business, project, and issues approximately up to 25% of time.
  • Other duties and projects, as assigned

Requirements:

  • BS in Engineering
  • Minimum of five years’ experience in engineering or Quality engineering experience within the medical device, pharmaceutical, or equivalent industry
  • 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

Nice to have:

  • Quality Engineering Certification (ASQ) or equivalent
  • Understanding of Medical Electrical Equipment including IEC 60601
What we offer:
  • A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
  • It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
  • At BD, you’ll discover a culture in which you can learn, grow, and thrive.
  • And find satisfaction in doing your part to make the world a better place.

Additional Information:

Job Posted:
March 01, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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