Senior Quality Technology Leader – Regulated Systems

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company matching

Parental leave

Paid holidays & PTO

Job summary

Integer Holdings is seeking a strategic leader to define and govern digital quality technologies across FDA-regulated environments. Partner with Global Quality Systems leadership to set strategy, roadmaps, and measurable objectives for QMS, MES, LMS and related platforms.

You will lead a cross-functional team, ensure data integrity, regulatory compliance, validation, and audit readiness while driving adoption of AI-enabled, risk-based quality practices.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Information Systems, or related field.
• 8+ years in Quality, IT, Operations, or related roles in FDA-regulated environment.
• 3+ years of supervisory or leadership experience.
• Experience implementing, validating, governing, or sustaining technologies in FDA-regulated environments.
• Ability to drive adoption balancing compliance, user experience, and business value.

Responsibilities

• Define QMS technology strategy, roadmaps, and measurable objectives with Global Quality Systems.
• Align stakeholders on scalable tech solutions supporting business strategy and global quality priorities.
• Quantify value of quality technology programs by improvements in quality, compliance, productivity, and cost.
• Provide leadership for acquisition integration, new site adoption, and digital transformation.
• Ensure validation, data integrity, electronic records, and audit readiness across systems.
• Lead a team for digital quality enablement, training governance, and enterprise platform support.
• Represent Integer in external advisory groups to share best practices.

Skills

Quality technology leadership

Cross-functional leadership

Regulatory compliance

Data integrity

Regulatory validation

Education

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

Tools

QMS

MES

LMS

Job description

Integer Holdings is seeking a strategic leader to define and govern digital quality technologies across FDA-regulated environments. Partner with Global Quality Systems leadership to set strategy, roadmaps, and measurable objectives for QMS, MES, LMS and related platforms.

You will lead a cross-functional team, ensure data integrity, regulatory compliance, validation, and audit readiness while driving adoption of AI-enabled, risk-based quality practices.