BD (Becton, Dickinson and Company) Quality Engineer I in Salt Lake City, Utah

Job ID: 2018-11772

Career Level: entry level

Division: Bard Peripheral Vascular

Relocation: No

Location: Salt Lake City,Utah,United States


Becton, Dickinson Interventional (BDI) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 65,000 people across 50 countries around the world. Founded more than 100 years ago, BDI pioneered many devices that are cornerstones of modern healthcare. BD - PI is the vascular division within BDI and focusses on interventional products for peripheral arterial disease (PAD), end stage renal disease (ESRD), and Cancer.

We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness, respect, and feel valued, acknowledged and rewarded.

Be Your Best at BD-PI – and ultimately, you can have an impact on the lives of people around the world.

Summary of Position with General Responsibilities:

This position develops implements and improves new and existing product quality requirements.

Essential job Functions:

  1. Assess risk associated with non-conforming material and determine disposition of affected product.

  2. Initiate new/revised documentation and tracks through approval cycles and implementation.

  3. Participate on cross-functional teams to develop risk assessment.

  4. Develop physical and functional test methods to ensure specifications are met.

  5. Write and/or review design verification and validation protocols and reports.

  6. Develop processes validation requirements (IQ, OQ, PQ) and equipment qualifications.

  7. Conduct and /or coordinate testing outlined in protocols and test methods.

  8. Perform process improvement, control and monitoring on manufacturing processes.

  9. Provide technical direction during design transfer activities.

  10. Conduct complaint investigations.

  11. Initiate Quality Event and CAPA investigations. Develop action plans to correct identified issues.

  12. Participate and provide input to training on department/division procedures, and policies.

  13. Participate in project planning, budgeting, scheduling and tracking.

  14. Participate in internal and supplier audits.

  15. Develop and implement procedures to provide easy to follow instructions.

  16. Understand and follow company procedures on regulatory requirements.

  17. Provide positive example and actively promote compliance to all standards.

  18. Maintain a professional working relationship with internal and external customer and support staff.

  19. Prepare and present project updates and technical discussions.

Basic Qualifications:

  • Working knowledge of FDA GMP/GLP, Medical Device Directive, and ISO.Ability to make and present engineering decisionsStrong interpersonal skillsComparative statisticsEngineering cost analysisAbility to analyze and optimize manufacturing and quality systemsAbility to create and provide trainingSoftware application skillsProblem solving abilityAbility to create, review and coordinate test protocols and reportsAbility to generate engineering proposalsOral and written presentation skillsAbility to work on cross functional teamsMust read, write and understand English. Must be detailed in handling information/data.Basic product, design & prototyping skills Proficient with Microsoft ExcelFamiliar with Minitab and Statistical Analysis

Additional Desirable Qualifications Skills and Knowledge:

Prefer two years experience in the medical field or closely related industry.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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