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Business Analyst

EXTRA HOLIDAYS
Remote: 
Full Remote
Contract: 
Salary: 
99 - 163K yearly
Experience: 
Mid-level (2-5 years)
Work from: 

Offer summary

Qualifications:

Bachelor of Engineering or Technology, 2 years of documentation practices experience, Familiarity with ISO 13485 and CFR regulations.

Key responsabilities:

  • Create and maintain product development documentation
  • Track quality system documentation in the life cycle
  • Maintain Design History Files for product releases
  • Audit project folders for required documentation
  • Serve as information source for teams during quality issues
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BD XLarge https://www.bd.com/
10001 Employees
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Job description

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Job Description Summary
The Business Analyst is responsible for authoring, formatting, tracking, storing, reviewing, updating, and maintaining control over documentation. These documents include policies, procedures, work instructions, forms, records, design deliverables etc. The individual is responsible for maintaining R&D product development documentation and ensuring compliance with internal policies, procedures, industry standards, and regulations. This position acts as an information source for R&D, quality and Regulatory teams.

P3-11578

Job Description

We are the makers of possible 

 

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. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Responsibilities

  • Create and maintain hardware and software product development life cycle documentation, including design inputs, design outputs, design verification, design validation and risk management deliverables in partnership with Engineering teams

  • Track quality system documentation through the product development life cycle, including preparing meeting minutes for design reviews, document change orders and updates, and revising product documentation and forms as needed.

  • Maintain responsibility for necessary DHF (Design History Files) at the close of each product release

  • Audit DHF project folders to ensure all the required documentation has been completed and is readily available within the QMS

  • Function as an information source to Engineering and other cross functional subject matter experts when quality issues arise

Skills and Competencies

  • Excellent written and verbal communication skills

  • Excellent organizational skills with a high level of attention to detail

  • Comfortable learning tools and technologies- TFS, SAP, ADO and JIRA

  • Ability to self-initiate and work independently on projects

  • Ability to manage multiple concurrent projects from initiation to completion

  • Ability to generate content on technical topics

  • Ability to effectively collaborate with team members and across functional areas

Qualifications and Experience

  • Bachelor of Engineering or Technology, Technical Writing related field or equivalent

  • 2 years of work experience in any industry with solid understanding of documentation practices

  • Familiarity with ISO 13485: 2016, ISO 14971: 2019, 21 CFR 820 regulations.

  • Experience with software development in a regulated field is preferred

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

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.  

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 health. 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.  

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

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, or any other protected status. 

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Primary Work Location
USA CA - San Diego TC Bldg C&D

Additional Locations

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.  We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$99,000.00 - $163,300.00 USD Annual

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Organizational Skills
  • Independent Thinking
  • Collaboration
  • Verbal Communication Skills
  • Detail Oriented

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