Quality Engineer Lead, Regulated MedTech

Regulatory Jobs; Sparks Corner (MD); On-site; USD 118,000 - 189,000; Full time

Job summary

BD in Sparks, MD seeks a Quality Engineer to drive Quality System compliance and SOP development for instrument manufacturing. You will guide CAPA, supplier qualification, and data analysis while supporting audits and regulatory requirements.

The role emphasizes on-site collaboration (minimum four days per week) to foster cross-functional problem solving and accountability within a regulated healthcare environment.

Qualifications

• Bachelor's degree and 10 years experience in a regulated environment.
• Master's degree and 5 years experience in a regulated environment.
• 5 years of experience in Quality Engineering.
• Certification in ASQ-CQA/CQE, AAMI, AOAC, and/or Six Sigma (Green/Black Belt preferred).

Responsibilities

• Interpret and apply Quality System requirements and develop/maintain SOPs and policies within the instrument manufacturing plant.
• Make key decisions to support critical organizational objectives.
• Support diagnostic instruments throughout the product lifecycle including manufacture, distribution, and post-market surveillance.
• Lead major quality system and business initiatives as project manager and report status to leadership.
• Provide expert guidance across Quality System elements and drive continuous improvement (internal/external).
• Apply statistical tools and data analysis to identify trends, root causes, and drive corrective actions.
• Support internal and external audits, ensuring readiness and compliance.
• Deliver training and mentorship on Quality Principles across cross-functional teams.
• Identify issues that may delay products or projects and recommend actions.
• Ensure documentation processes are compliant with regulatory standards.

Skills

Quality engineering

CAPA

Six Sigma

Project management

Root cause analysis

Regulatory knowledge

Data analysis

FDA 21 CFR 820

ISO 13485:2016

Education

Bachelor's degree in a regulated environment

Master's degree in a regulated environment

Tools

Six Sigma tools

CAPA processes

Job description

BD in Sparks, MD seeks a Quality Engineer to drive Quality System compliance and SOP development for instrument manufacturing. You will guide CAPA, supplier qualification, and data analysis while supporting audits and regulatory requirements.

The role emphasizes on-site collaboration (minimum four days per week) to foster cross-functional problem solving and accountability within a regulated healthcare environment.