Government, Regulatory and Code, Pharmaceutical, Quality, Quality Engineering
BIOLYPH is growing! We are seeking an experienced, team-oriented and responsive Quality Engineer. This position will be responsible for supporting the performance of BIOLYPH's Quality Management System (QMS) in alignment with BIOLYPH's business model of producing our Clients' IVD/RUO products Effectively, Efficiently and Economically.
Established in 1993, BIOLYPH is a dynamic, rapidly growing, World Class Contract Lyophilization and Packaging Service Company located in Chaska, Minnesota. Our Clients honor us with double-digit growth for the past 26 years.
Employees are BIOLYPH's most valuable asset. This is evident by our friendly work environment filled with high quality, engaged employees.
This position joins a team that supports collaboration, continuous improvement, and opportunities for personal and professional growth.
This Position Frequently Interacts With:
Production Staff responsible for the full scope of manufacturing from Reagent Manufacturing to Final Assembly
Support the performance of BIOLYPH's Quality Management System (QMS) based on 21 CFR 820 and ISO 13485:2016
Ensure clear policies, procedures, instructions, and forms exist to support production
Provide measurement methodologies and will assist in problem solving activities
Perform all job duties per the documented work instructions as BIOLYPH provides services for regulated in vitro diagnostic devices
Production Support and Monitoring: Develops quality plans, such as FMEAs, Control Plans, and SPC, when required. Ensures processes in use are appropriately documented and controlled. Periodically analyzes technical and QMS data. As needed, provides management reports on the cost of quality.
Internal Audit System: Provides oversight of the Internal Audit System to include the performance, documentation, and monitoring of internal audits.
Corrective Action and Preventive Action: Works cross-functionally to identify and resolve quality problems. Performs and documents root cause and corrective action investigations, as necessary, to meet Client needs and to improve the QMS.
Proactive Quality: Uses statistical analysis and Six Sigma tools and techniques to analyze data and identify improvement opportunities.
Validation System: Provides support across the Validation process (protocol development, protocol execution, data review, and validation report authorship), as requested by the QA Manager.
Supplier Management System: Surveys and monitors suppliers/subcontractors and assists suppliers with quality improvement methods, as requested by the QA Manager.
Expected Hours of Work:
Full-time, Monday through Friday 7:00 a.m. to 4:00 p.m.
Minimal travel required
Preferred Skills & Experience:
Experience in the IVD Industry
Validation protocol development or execution
Certifications such as: CQE, CQA, CRE, or Six Sigma Black Belt
Competitive pay commensurate with experience
Company sponsored events
Clean, friendly, and comfortable work environment
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
Employee Assistance Program
Are you ready to join our team?
If you feel like you are qualified for this opportunity, please email a letter of introduction, resume and salary requirements to email@example.com or apply online at www.BIOLYPH.com.
Bachelor's Degree: Engineering degree, preferred. Other degrees may be considered with applicable experience in a similar Quality Engineering role.
5+ years of QA experience in a FDA regulated industry
Working knowledge of 21 CFR 820 and ISO 13485:2016
Experience in performing Risk Assessments and Root Cause Analysis investigations
Understanding of statistical tools and techniques (DOE, sampling distributions, Capability studies, etc.)
Well organized, pays attention to details
Excellent computer skills (Outlook, Word, Excel)
Outstanding technical writing skills
About BIOLYPH, LLC
BIOLYPH, established in 1993, is a Biotechnology Manufacturing Service Company specializing in lyophilization located in Chaska, Minnesota. Our customers are manufacturers of Diagnostic and Life Science Research Products.
BIOLYPH believes our employees are a valuable asset. We offer professional development to expand your skill set and enhance your career. You will be working in a family-friendly environment with a great team of co-workers and managers. At BIOLYPH, your work will impact lives including your own!