Senior Quality Technology Leader – Regulated Systems

Regulatory Jobs; United States; À distance; USD 128 000 - 188 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Adoption benefits

401(k) with company match

Paid time off

Résumé du poste

Integer is seeking an experienced leader to drive Strategy, Roadmap and Value Acceleration for regulated quality technology. You will partner with Global Quality Systems to define priorities, roadmaps, and measurable objectives, aligning stakeholders across Quality, IT, and Operations to deliver scalable solutions that improve compliance, productivity, and user experience.

The role emphasizes governance, validation, data integrity, and change control across enterprise platforms, with a focus on

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related technical field.
• 8+ years of experience in Quality, IT, Operations, or related functions within an FDA-regulated environment.
• 3+ years of supervisory or leadership experience.
• Experience implementing, validating, governing, or sustaining technologies used in FDA-regulated environments including QMS, MES, LMS, and related enterprise platforms.
• Ability to drive adoption of new technology balancing compliance, user experience, business value, and operational practicality.

Responsabilités

• Define QMS technology strategy, annual priorities, roadmaps, and measurable objectives with Global Quality Systems leadership.
• Align stakeholders on scalable technology solutions that support business strategy, customer expectations, and global quality priorities.
• Quantify value of quality technology programs—quality, compliance, productivity, cost, speed, and user experience.
• Translate quality technology needs into business cases, requirements, governance, and execution plans.
• Provide quality technology leadership for acquisition integration, site adoption, and digital transformation.
• Ensure regulatory requirements, risk management, validation, data integrity, change control, and lifecycle sustainment are defined and maintained.
• Lead adoption of data-driven, AI-enabled, risk-based CSA approaches for modernized regulated quality technology.
• Support audit readiness for enterprise quality systems and regulated technologies, including validation and training records.

Connaissances

Cross-functional leadership

Regulatory knowledge

Strategic thinking

Communication

Problem solving

Formation

Bachelor's degree in Engineering/Life Sciences/Information Systems

Outils

QMS

MES

LMS

Electronic records systems

Description du poste

Integer is seeking an experienced leader to drive Strategy, Roadmap and Value Acceleration for regulated quality technology. You will partner with Global Quality Systems to define priorities, roadmaps, and measurable objectives, aligning stakeholders across Quality, IT, and Operations to deliver scalable solutions that improve compliance, productivity, and user experience.

The role emphasizes governance, validation, data integrity, and change control across enterprise platforms, with a focus on