Senior Quality Manager - QMS & Compliance Leader

Biolyph Llc; Chaska (MN); On-site; USD 125,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401k

Paid time off

Life insurance

EAP (Employee Assistance Program)

Company events

Job summary

BIOLYPH, based in Chaska, MN, is seeking a Senior Quality Manager to lead the Quality Department and own the Quality Management System. This full-time role offers a 4- or 5-day work week, competitive benefits, and strong life–work balance.

You will set the strategic vision for quality, supervise staff, coordinate cross‑functional initiatives, and ensure ISO 13485 and FDA/cGMP compliance across the organization.

Qualifications

• Bachelor's degree in Life Sciences or Chemistry.
• Five+ years in a Quality Leader role.
• Quality Assurance in FDA-regulated environments.
• GMP/GDP experience.
• ISO 13485 experience preferred.
• Quality certifications preferred.

Responsibilities

• Maintain a QMS aligned with ISO 13485 and 21 CFR Part 820 through documentation and training.
• Lead the Quality Department, hire and manage staff, and report to Executive Management.
• Develop and communicate quality objectives aligned with BIOLYPH policies.
• Perform management reviews and monitor QMS deliverables.
• direct supplier audits and quality investigations.

Skills

Quality leadership

QMS

Regulatory compliance

GMP/GDP

ISO 13485

Continuous improvement

Documentation control

Education

Life Sciences degree

CQIA/CMQ/CQE

Job description

BIOLYPH, based in Chaska, MN, is seeking a Senior Quality Manager to lead the Quality Department and own the Quality Management System. This full-time role offers a 4- or 5-day work week, competitive benefits, and strong life–work balance.

You will set the strategic vision for quality, supervise staff, coordinate cross‑functional initiatives, and ensure ISO 13485 and FDA/cGMP compliance across the organization.