Spec, Documentation

About the role

BD is one of the largest global medical technology companies in the world. We advance the world of health by designing, engineering, manufacturing, and marketing billions of MedTech products each year. This role supports the Change Control and APM (Advanced Product Management) processes for Irvine and international locations, ensuring compliance, facilitating timely project completion, and identifying opportunities for improvement.

Responsibilities

• Review APM procedures and interact with document owners to ensure compliance with standard procedures and regulations.
• Support the Change Control process for Irvine and International sites, guiding users on the process and processing change requests.
• Support special projects (e.g., new product launches, sustaining changes, training assignments, records retention, CAPAs, SA) in collaboration with team members; identify and propose solutions for improvement.
• Ensure documents are delivered on time to facilitate project completion.
• Follow up with Change owners to ensure all pending activities for implementation are completed.
• Maintain accurate records of APM documentation and improve Quality System Documents.
• Support Change Control metrics by producing reports on document updates, change requests, and periodic reviews.
• Support internal and external audits, including conducting regular document audits.
• Serve as a conduit between departments to promote cohesive strategies addressing quality issues and mitigating risks.

Requirements

• Minimum 5 years of previous related experience.
• Bachelor’s degree or Associate’s degree in a related field (preferred).

Skills

• Strong communication and interpersonal skills.
• Excellent written and verbal communication abilities.
• Proficiency in Microsoft Office Suite.
• Strong problem-solving skills and attention to detail.
• Ability to manage confidential information with discretion.
• Ability to work in a team environment under general supervision.
• Ability to build stable working relationships internally.
• Adherence to company rules and requirements.

Benefits

BD offers a comprehensive Total Rewards program, including competitive compensation, benefits, and opportunities for reward and recognition. We foster a culture of face-to-face collaboration to support learning, progress, and success.

Pay

Salary range: $83,500.00 – $133,500.00 USD annually. The final offer is determined by role requirements, necessary skills, education, and applicable labor laws or Collective Bargaining Agreements.

Primary work location: USA CA - Irvine Laguna Canyon.