Senior Quality Documentation & Records Lead

Integer Holdings Corporation; Plymouth (MN); On-site; USD 34,000 - 50,000; Full time

Benefits offered by this job

Medical, dental, vision, disability, &

Life insurance & adoption benefits

401(k) plan with company matching

Holiday leave & PTO

Parental leave after one year

Job summary

Integer Holdings Corporation in Plymouth, MN is seeking a Documentation Administrator to support GMP-compliant documentation activities within the Quality function. You will control document distribution, maintain records, and assist with audits while following GDP/QMS guidelines.

The role requires strong organizational and communication skills, with a focus on training staff and driving continuous improvements in process quality.

Qualifications

• Diploma in administration preferred.
• 4+ years of experience.
• Experience gained on the job.
• Leadership and mentoring for junior staff
• Strong written and oral communication
• Excellent organization and time management
• Proficient in MS Office and document systems
• Knowledge of GMP, GDP, QMS ISO standards

Responsibilities

• Support documentation administration within Quality following GMP and GDP.
• Control distribution and retrieval of documents.
• Notify functions when local external documents change.
• Manage access to on-site and off-site records.
• Perform annual record disposition review.
• Review Device History Record (DHR) per procedures.
• Assist audits and support other departments.
• Train personnel on systems and processes.
• Drive process improvements and quality KPI attainment.

Skills

Leadership

Communication

Time management

Documentation systems

MS Office

ISO 9001

ISO 13485

FDA 21 CFR 820

Office management

Team mentorship

Education

Diploma in Administration

Tools

Microsoft Teams

Excel

Word

Job description

Integer Holdings Corporation in Plymouth, MN is seeking a Documentation Administrator to support GMP-compliant documentation activities within the Quality function. You will control document distribution, maintain records, and assist with audits while following GDP/QMS guidelines.

The role requires strong organizational and communication skills, with a focus on training staff and driving continuous improvements in process quality.