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The Difference of One

At BD Becton Dickinson & Co., you’re one person making one big difference. You’re a key member of a team that is an important part of a leading, purposeful company committed to advancing the world of health. No matter what role you play, you can be confident that you’re improving lives, all over the world. And as you progress with us, your impact will only grow.

By being hired into one of our Quality Engineer jobs at BD, you’ll be a key member of the BD team. Professionals in Quality Engineer careers come from a variety of backgrounds, bringing an assortment of knowledge and skills to every area of our business. A Quality Engineer job at BD may be waiting for you!

Staff I, Engineer, Quality Systems

Job ID R-17240 Date posted 08/11/2017

Job Description Summary

As directed by the Associate Quality Director, the Staff Quality Engineer I is accountable for support in the continued development, improvement, and expansion of the Diabetes Care WW Quality Management System as well as maintaining compliance with regulations, standards, and Corporate requirements. This position provides collaborative support to quality system leadership and may work with other functions within the organization including Operations, Quality, R&D, Procurement, Marketing, Regulatory and Medical in addition to corporate functions, regulatory agencies and suppliers.

Job Description

Responsibilities:

  • Coordinate quality systems and processes to ensure compliance with Quality System and regulatory requirements and promote quality improvements.
  • Develop and make updates to applicable Site / Unit procedures and policies
  • Provide a quality review on a range of quality documentation including Unit Policies, Procedures, Investigations, Change Controls, GMP records and other Quality Management Systems Documentation as required.
  • Lead unit-level quality system processes and systems (SAP, TrackWise, ECC, DMS, etc) for CAPA, audit, Quality notification, calibration, supplier management, document and change control.
  • Ensure investigations are conducted and adequately resolved in a timely manner with appropriate CAPAs in place to prevent reoccurrence of issues.
  • Conducts or leads internal audits and supplier audits.

Experience and Education:

  • A minimum of 8 years relevant experience or a combination of higher education and relevant experience.
  • Bachelor’s Degree. MS preferred.
  • Certified Quality Engineer and Certified Quality Auditor (preferred).

Knowledge, Skills and Abilities:

  • Strong knowledge of 21CFR820/210/211/11, ISO 9001, ISO 13485 and other applicable medical device regulations.
  • Understanding of continuous improvement methodologies including Lean, Six Sigma, SPC, etc. is desired.
  • Ability to support internal / external audits.
  • Excellent communication, problem solving, organizational and interpersonal skills are essential.
  • Full proficiency in Microsoft Office required
  • Self-motivated and directed, requiring minimal supervision
  • Demonstrated ability to work in teams to obtain results is required.
  • Effective skills in analytical thinking and problem solving required.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift

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Why Join BD?

  • Become an integral part of a company that makes a difference in human health, saving and improving the lives of people in all corners of the globe.
  • Use your creativity and entrepreneurial spirit to develop innovative solutions and products that can benefit all people around the world.
  • Enjoy an array of very competitive benefits, including choices of medical programs, company-sponsored savings plan, on-site fitness centers at select locations, tuition reimbursement, and many others that support a healthy lifestyle.
  • Become part of a company that gives significant time, talent and resources to philanthropic and charitable efforts around the world.

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