Staff Quality Systems Specialist I

BD; Franklin Lakes (NJ); On-site; USD 135,500 - 216,800; Full time

Job summary

BD in the United States is seeking a Quality Assurance leader to drive CAPA, audits, and quality-system activities at the Franklin Lakes site. You will collaborate with Quality Engineering, R&D, Operations, and other functions to implement policies and improve performance.

This role requires a BS in Engineering or related field and at least eight years in medical device or related industries. You will coordinate with internal and external audits (FDA/ISO), manage CAPA board activities, and

Qualifications

• BS degree in Engineering, Science, or related discipline
• 8+ years of medical device, biologic, pharmaceutical, or diagnostic industry experience
• Strong knowledge of US and International regulations and standards (21 CFR 820, ISO 13485, MDD/MDR, MDSAP)

Responsibilities

• Develops and updates site/unit procedures and work instructions.
• Acts as Site CAPA Leader; SME on CAPA content and Trackwise usage.
• Leads site CAPA Board meetings and coordinates with WW CAPA Board.
• Handles site audits and ensures compliance with FDA, ISO, and other audits.
• Coordinates Quality Notifications (NCs and Planned Deviations) content and activities.
• Leads or supports root-cause analysis and problem-solving with cross-functional teams.
• Tracks trends in CAPA, Audits, QNs and reports metrics.
• Maintains site and WW Quality Systems and supports continuous improvement.
• Collaborates with Quality Eng, R&D, Operations, Medical, Marketing on policy development.

Job description

Job Description

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.

Job Responsibilities

• Develops applicable Site / Unit procedures / work instructions and may make updates to Unit level procedures and policies.
• Serves as the Site CAPA Leader
  • Acts as Subject Matter Expert to CAPA end users regarding CAPA content and Trackwise utilization.
  • Leads site CAPA Board meetings and liaises with the WW CAPA Board to ensure timely completion of CAPA activities and identify areas of improvement/escalation
• Serves as the site Audit Manager
  • Collaborates with the PS Internal Audit Program Manager to assess risks and ensure site internal audit requirements are met
  • Ensures systematic execution of all required internal, external (FDA, ISO, etc.) and customer audits
  • Supports pre‑ and post‑inspection activities, which may include but are not limited to hosting and logistics, coaching subject matter experts, record review, and tracking of responses, actions and other audit closure activities.
  • Acts as Subject Matter Expert regarding audit process and electronic tools utilization.
• Serves as the site coordinator for Quality Notifications (NCs and Planned Deviations)
  • Acts as Subject Matter Expert regarding QN content, process, and electronic tools utilization
  • Supports end users in meeting timely completion of QN related activities
• Leads or supports problem‑solving and root cause analysis activities, as needed. Coaches cross‑functional teams as a problem‑solving subject matter expert.
• Tracks trends of various Quality Data sources (CAPA, Audits, QNs, etc.). Analyzes and reports on metrics.
• Assists with Management Review content development and related activities.
• Maintains Site and WW Quality Systems. Supports continuous improvement initiatives.
• Collaborates with cross‑functional partners such as Quality Engineering, R&D, Operations, Medical, Marketing to seek their input into the development of policies and procedures, and their support in addressing Quality Issues.

Education and Experience

• BS degree in Engineering, Science, or other related discipline
• At least 8 years of medical device, biologic, pharmaceutical, or diagnostic industry experience.

Knowledge and Skills

• Strong knowledge of US and International regulations and standards that apply to the medical device industry including 21CFR820, ISO 13485, MDD/MDR, MDSAP country requirements as well as other requirements applicable to the product.
• Proficient communication, organizational and interpersonal skills.
• Ability to perform multiple tasks and prioritize workload. Self‑motivated / directed, require minimum supervision
• Effective analytical, technical, and problem‑solving skills.
• Effective meeting and presentation skills.
• Ability to perform and/or host internal / external audits.
• Collaborative ability to work in teams to obtain desired results.

Location

Primary Work Location: USA, NJ - Franklin Lakes

Salary Range

$135,500.00 - $216,800.00 USD Annual

Equal Opportunity Employer

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.