Senior Quality Technology Leader - Regulated Systems

Integer Holdings; Plano (TX); On-site; USD 128,000 - 188,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) matching

Paid time off

Job summary

Integer Holdings in Plano, TX seeks a Senior Leader to guide digital quality enablement across GxP platforms. You will partner with IT, Quality, Operations to define strategy, roadmaps, and value metrics for QMS technology, validation, and data integrity.

This role requires 8+ years in FDA-regulated environments, 3+ years leading teams, and a proven ability to balance compliance with user experience and business value.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Information Systems, or a related technical field is required.
• 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.

Responsibilities

• Define QMS technology strategy, annual priorities, roadmaps, and measurable objectives.
• Align stakeholders on standard, scalable technology solutions that support business strategy, customer expectations, and global quality priorities.
• Quantify the value of quality technology programs, including improvements in quality, compliance, productivity, cost, speed, and user experience.
• Translate emerging quality technology needs into business cases, user and functional requirements, governance expectations, and execution plans.
• Provide quality technology leadership and design-authority input for acquisition integration, new site adoption, digital transformation and enterprise programs that impact regulated quality processes.
• Ensure requirements, intended use, regulatory risk, validation strategy, data integrity, electronic records, change control, and sustainment needs are defined and maintained through the system lifecycle.

Skills

Regulated quality tech

Cross-functional leadership

CSV/CSA

Regulatory knowledge

Education

Bachelor's degree in Engineering

Tools

QMS

MES

LMS

Enterprise platforms

Job description

Integer Holdings in Plano, TX seeks a Senior Leader to guide digital quality enablement across GxP platforms. You will partner with IT, Quality, Operations to define strategy, roadmaps, and value metrics for QMS technology, validation, and data integrity.

This role requires 8+ years in FDA-regulated environments, 3+ years leading teams, and a proven ability to balance compliance with user experience and business value.