Senior Quality Engineer – CAPA & Regulatory Systems

BD; Cockeysville (MD); On-site; USD 118,000 - 189,000; Full time

Benefits offered by this job

On-site collaboration

Job summary

BD is seeking a senior quality engineering leader to oversee the interpretation and application of Quality System requirements in a high‑volume instrument manufacturing setting. You will develop SOPs, manage major quality initiatives, and guide cross‑functional teams through regulatory and process improvements.

You will drive CAPA, supplier qualification, and audit readiness while mentoring others in Quality principles and best practices across the organization.

Qualifications

• Bachelor’s degree plus 10 years in a regulated environment.
• Master’s degree plus 5 years in a regulated environment.
• Minimum 5 years of experience in Quality Engineering.
• Certification in ASQ-CQA/CQE, AAMI, AOAC, and/or Six Sigma

Responsibilities

• Interpret and apply Quality System requirements and SOPs in an instrument manufacturing plant.
• Lead/participate in major quality system and business initiatives as project manager.
• Support diagnostic instruments across the medical device lifecycle (manufacture, distribution, post-market).
• Provide guidance on process control, supplier qualification, and continuous improvement.
• Lead audits readiness and compliance activities.
• Deliver quality engineering concepts and training across teams.

Skills

Quality Engineering

CAPA

Six Sigma

Regulated environment

Education

Bachelor's degree in a regulated environment

Master's degree in a regulated environment

Job description

BD is seeking a senior quality engineering leader to oversee the interpretation and application of Quality System requirements in a high‑volume instrument manufacturing setting. You will develop SOPs, manage major quality initiatives, and guide cross‑functional teams through regulatory and process improvements.

You will drive CAPA, supplier qualification, and audit readiness while mentoring others in Quality principles and best practices across the organization.