Senior Quality Technology Leader

Integer Holdings Corporation

Northern (KY)

Hybrid

USD 128,000 - 188,000

Full time

8 days ago

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Benefits offered by this job

Medical, dental, vision benefits
401(k) with matching contributions
Paid holidays and time off

Job summary

Integer Holdings Corporation seeks a senior leader to guide digital quality enablement across regulated environments in the United States. You will define technology strategy for QMS, CSA, and related platforms, align stakeholders, and drive value through data-driven decisions.

You will build and lead a global team, ensure compliance with FDA and ISO standards, and partner with IT and Operations to accelerate digital transformation while maintaining audit readiness.

Qualifications

  • Bachelor’s degree in Engineering, Life Sciences, Information Systems, or related field.
  • 8+ years in Quality, IT, Operations in FDA-regulated environment.
  • 3+ years of supervisory or leadership experience.
  • Experience implementing, validating, governing, or sustaining technologies in FDA-regulated environments (QMS/MES/LMS).

Responsibilities

  • Define QMS technology strategy, priorities, roadmaps and objectives.
  • Align stakeholders on scalable technology solutions supporting strategy and quality.
  • Quantify value of quality tech programs including improvements in quality and compliance.
  • Translate needs into business cases, requirements, governance and execution plans.
  • Provide technology leadership for acquisitions, new site adoption and digital programs.

Skills

Regulated quality tech
CSV/CSA
Electronic records
Data integrity
Lifecycle governance

Education

Bachelor's degree in Engineering/Life Sciences/IS

Tools

QMS
MES
LMS
Enterprise platforms

Job description

Integer Holdings Corporation seeks a senior leader to guide digital quality enablement across regulated environments in the United States. You will define technology strategy for QMS, CSA, and related platforms, align stakeholders, and drive value through data-driven decisions.

You will build and lead a global team, ensure compliance with FDA and ISO standards, and partner with IT and Operations to accelerate digital transformation while maintaining audit readiness.

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