Manager, Quality Assurance

TL;DR

Manager, Quality Assurance (Quality Systems/Regulatory Compliance): Developing, implementing, and maintaining quality systems and compliance programs for an active diagnostics organization with an accent on audits, supplier quality, CAPA, complaints, and field actions. Focus on strengthening regulatory readiness, managing corrective actions, and coordinating quality activities with supplier sites.

Location: Onsite in Rockville, Maryland, USA; the role requires up to 30% travel to supplier sites.

Salary: $116,600–$177,800 annual base salary, with potential discretionary or non-discretionary bonuses.

Company

Develops diagnostic products and technologies supported by regulated quality and compliance systems.

What you will do

• Develop, implement, and maintain quality systems aligned with corporate policies and active regulatory certifications.
• Manage internal audit programs and follow up on audit findings.
• Oversee supplier quality activities and travel to supplier sites as needed.
• Coordinate corrective and preventive actions, including CAPA investigations and effectiveness monitoring.
• Manage product complaints and field actions in collaboration with relevant stakeholders.

Requirements

• Experience managing quality systems and regulatory compliance programs.
• Knowledge of internal audits, supplier quality, CAPA, complaints, and field actions.
• Ability to work in a standard office environment and travel up to 30% to supplier sites.
• Ability to work onsite in Rockville, Maryland, USA.
• Employment eligibility in the United States is required; work eligibility is validated through E-Verify.

Culture & Benefits

• Medical, dental, vision, and prescription coverage.
• 401(k) plan with company matching and flexible spending accounts.
• Company-paid short- and long-term disability insurance and group life insurance.
• Paid vacation, sick leave, holidays, and parental leave.
• Additional benefits include an employee assistance program, fitness club contribution, pet insurance, identity theft protection, and insurance discounts.