Quality Assurance Manager

About the role

We are seeking an experienced, team-oriented, and responsive Quality Assurance Manager. This full-time position offers your choice of a 4 or 5 day work week, competitive benefits, growth opportunities, and a culture of life-work balance.

Responsibilities

• Execute and maintain assigned QMS subsystems in alignment with ISO 13485 and 21 CFR 820 requirements

• Monitor and analyze quality metrics (NCRs, CAPAs, complaints, audit findings) and escalate risks or adverse trends

• Drive timely closure and effectiveness of quality records

• Own and manage CAPA, Nonconformance, and Complaint Handling systems, ensuring:

  • Timely initiation, investigation, and closure
  • Robust root cause analysis (5 Whys, Fishbone, etc.)
  • Verification of effectiveness (VOE)
  • Identify systemic issues and escalate to Senior Quality Manager as needed

• Lead internal audits and support external audits (Client, registrar, regulatory)

• Serve as primary point of contact for audit logistics, responses, and follow-up actions

• Ensure audit observations are appropriately documented, investigated, and trended

• Champion BIOLYPH's goal of Perfect Finished Parts and promote a culture of continuous improvement

• Provide real-time quality support to manufacturing operations

• Ensure product and process adherence to specifications and procedures

• Partner with Engineering and Operations to resolve quality issues and prevent recurrence

• Maintain strong, professional relationships with Client Quality representatives

Qualifications

• Bachelor's Degree in Life Sciences, Engineering, or related field

• Minimum 7 years of experience in quality assurance within a regulated industry, with a minimum of 2 years of experience in a management role

• Experience with quality subsystem ownership

• Experience supporting external audits (preferred)

• Strong knowledge of QMSR (21 CFR 820), ISO 13485, ISO14971 and MDSAP (preferred)

• Quality certification, CQIA, CMQ, or CQE (preferred)

Secondary Job Functions

• Perform miscellaneous duties and projects as required

Qualifications

• Strong problem-solving, communication, and documentation skills

• Interpersonal, negotiation, time management, and prioritization skills

• Demonstrated use of risk-based thinking

• Well organized, pays attention to details

• Excellent computer skills (Outlook, Word, Excel)

• Capable of applying Quality Tools to diverse situations

• Proven leadership and team management experience

• Project Management

• Capable of working independently and as a team

• Must be able to wear appropriate PPE

• Ability to sit for extended periods of time

• Normal vision acuity (with or without corrective lenses)

• Ability to identify and distinguish colors

• Ability to lift 10lbs routinely/often/occasionally

• Ability to crouch, bend, twist and reach

About BIOLYPH

Established in 1993, BIOLYPH is a dynamic, World-Class Contract Lyophilization and Component Packaging Service Company located in Chaska, Minnesota. BIOLYPH has maintained a workforce that is collaborative and innovative. BIOLYPH Offers:

• Benefits for full-time employees include:
• Health, Dental, Vision, Life, Short-term, and Long-term disability insurance
• Paid Time Off, Paid Holidays, including Floating Holidays, Paid Birthdays
• 401k
• Employee Assistance Program
• Frequent company-sponsored events
• Clean, friendly, and collaborative work environment