Job Description
Job Description
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.
The Quality Assurance Manager is responsible for the execution, oversight, and continuous improvement of Quality Assurance processes supporting manufacturing and Client programs. The Quality Assurance Manager ensures effective implementation of the Quality Management System (QMS) through management of quality subsystems (CAPA, complaints, nonconformance, audits) and cross-functional support of day-to-day operations. This will be done in alignment with BIOLYPH’s business model of producing our Clients’ IVD/RUO products Effectively, Efficiently, and Economically.
Essential Functions:
- Quality Management System:
- 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
- Support Management Review through data preparation and trend analysis
- 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
- Audit System:
- 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
- Production Support:
- 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
- Client Support:
- Maintain strong, professional relationships with Client Quality representatives
Secondary Job Functions:
- Perform miscellaneous duties and projects as required
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)
Other Requirements:
- 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:
- Competitive pay commensurate with experience
- 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