Manager I, Validation (MedTech)

TL;DR

Manager I, Validation (MedTech): Developing and overseeing validation and calibration programs for facilities, equipment, and manufacturing processes to ensure regulatory compliance. Focus on risk-based validation strategies and maintaining audit readiness throughout the product lifecycle.

Location: Rockville, MD or Gaithersburg, MD, USA

Salary: $101,400–$154,650

Company

A company specializing in the development of high-performance diagnostic systems.

What you will do

• Develop, implement, and continuously improve validation and calibration programs.
• Provide leadership and oversight for validation activities across facilities, utilities, equipment, and computerized systems.
• Define and execute risk-based validation strategies throughout the product and process lifecycle.
• Ensure strict alignment with internal quality systems and regulatory standards.
• Maintain constant audit readiness for all validation and calibration activities.

Requirements

• Proven experience in developing validation and calibration programs in a regulated environment.
• Ability to provide technical leadership and oversight for complex validation activities.
• Deep knowledge of quality systems and applicable regulatory standards.
• Must be based in or able to work onsite in Rockville or Gaithersburg, Maryland.

Culture & Benefits

• Comprehensive medical, dental, and vision coverage with prescription benefits.
• 401(k) plan with company matching and flexible spending accounts.
• Paid vacation, sick leave, holidays, and parental leave.
• Company-paid short- and long-term disability and group life insurance.
• Additional perks including fitness club membership contributions and pet insurance.