QA Compliance Leader – ISO/FDA (Textiles)

Berkshire; Whitsett (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Life and Voluntary Life Insurance

Short- and Long-Term Disability

Flexible Spending with Company Match

401(k) Retirement Savings Plan with  –

Paid Holidays

Personal/Sick

EAP Program

Tuition Reimbursement

Job summary

Berkshire is seeking a Quality Control Manager to lead all QC laboratory operations across nonwoven, knitted, and textile materials, ensuring testing meets internal, customer, and regulatory specifications. The role requires extensive QC experience and a strong leadership track record in regulated environments.

The position emphasizes ISO 9001/22716/13485 and FDA 21 CFR Part 820 compliance, data integrity, CAPA, and collaboration with manufacturing, product development, and QA departments to

Qualifications

• 6+ years QC experience with 4+ years in a leadership role.
• Experience in textiles/nonwovens/knitted, controlled cleanroom and sterile manufacturing environments or regulated industries.
• Proficiency with ERP, LIMS, and data management practices.
• Ability to interpret specifications and ensure compliance with ISO 9001, ISO 22716, ISO 13485, and 21 CFR Part 820.

Responsibilities

• Oversee comprehensive QC laboratory operations—receiving, in-process, and finished goods testing.
• Ensure compliance with ISO/ FDA regulations and data integrity (ALCOA+).
• Lead laboratory personnel and support manufacturing and product development.
• Maintain lab records, calibrations, and QA/QC processes; manage CAPA and change control.
• Provide training, performance evaluations, and development for the QC team.

Skills

QC experience

Leadership

Textiles/nonwovens/knitted

GMP/GDP/ISO familiarity

MS Office/ERP/LIMS

Education

Bachelor’s degree in Chemistry/Biology/Microbiology/Engineering

Tools

ERP systems

LIMS

Microsoft Office

Job description

Berkshire is seeking a Quality Control Manager to lead all QC laboratory operations across nonwoven, knitted, and textile materials, ensuring testing meets internal, customer, and regulatory specifications. The role requires extensive QC experience and a strong leadership track record in regulated environments.

The position emphasizes ISO 9001/22716/13485 and FDA 21 CFR Part 820 compliance, data integrity, CAPA, and collaboration with manufacturing, product development, and QA departments to