Senior Quality Tech Leader - Regulated & Digital

Integer Holdings Corporation; United States; On-site; USD 128,000 - 188,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

Parental leave

401(k) with company match

Paid holidays

Job summary

Integer Holdings Corporation seeks a strategic leader to align Quality Systems, IT, and regulated operations. You will define the technology strategy, drive governance, and ensure data integrity across QMS, MES, LMS, and related platforms in FDA-regulated environments.

You will lead global teams, partner with stakeholders, accelerate value, and maintain audit readiness. A strong track record in CSV/CSA, regulatory standards, and cross-functional leadership is essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Information Systems, or a related technical field 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 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 supporting business strategy and quality priorities.
• Quantify value of quality technology programs including improvements in quality, compliance, productivity, cost, speed, and user experience.
• Translate emerging quality technology needs into business cases, requirements, governance, and execution plans.
• Provide quality technology leadership and design-authority input for acquisition integration and digital transformation.
• Ensure regulatory requirements, validation strategies, data integrity, electronic records, change control, and sustainment needs are defined throughout the lifecycle.
• Lead adoption of data-driven, AI-enabled, risk-based CSA approaches to modernize practices.
• Support audit readiness for enterprise quality systems and regulated technologies.

Skills

CSV/CSA

Electronic records

Data integrity

Lifecycle governance

Regulated quality knowledge

EU MDR / ISO 13485

Audit readiness

Education

Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related field

Tools

QMS

MES

LMS

Job description

Integer Holdings Corporation seeks a strategic leader to align Quality Systems, IT, and regulated operations. You will define the technology strategy, drive governance, and ensure data integrity across QMS, MES, LMS, and related platforms in FDA-regulated environments.

You will lead global teams, partner with stakeholders, accelerate value, and maintain audit readiness. A strong track record in CSV/CSA, regulatory standards, and cross-functional leadership is essential.