Job Summary: Quality Engineer primarily support 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.
Essential Job Functions:
Support the performance of BIOLYPH’s Quality Management System (QMS) based on 21 CFR 820 and ISO 13485
Ensure clear policies, procedures, instructions, and forms exist to support production
Provide measurement methodologies and assist in problem-solving activities
Production Support and Monitoring:
Develop quality plans, such as FMEAs, Control Plans, and SPC, when required
Ensure processes in use are appropriately documented and controlled
Periodically analyze technical and QMS data
As needed, provide management reports on the cost of quality
Internal Audit System:
Provide oversight of the Internal Audit System to include the performance, documentation, and monitoring of internal audits
Corrective Action and Preventive Action:
Work cross-functionally to identify and resolve quality problems
Perform and document root cause and corrective action investigations, as necessary, to meet Client needs and to improve the QMS
Use statistical analysis and Six Sigma tools and techniques to analyze data to identify improvement opportunities
Provide support across the Validation process (protocol development, protocol execution, data review, and validation report authorship), as needed
Supplier Management System:
Survey and monitor suppliers/subcontractors and assist suppliers with quality improvement methods
Work on projects assigned by Management
Experience / Education
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
Quality certification CPQA or CQE (preferred)
Working knowledge of 21 CFR 820 and ISO 13485
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
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 10 lbs routinely/often/occasionally
Ability to crouch, bend, twist and reach
Ability to push/pull 25 lbs occasionally
DEDICATED LYOPHILIZATION SERVICE PROVIDER
Established in 1993, BIOLYPH proudly serves Life Science, IVD, and RUO reagent manufacturers by converting their unstable proteins, antibodies, enzymes, immunochemical reagents, clinical chemistry reagents, and cells into stable LyoSpheres.
BIOLYPH has redefined the lyophilization paradigm by creating LyoSpheres precise and durable lyophilized microliter aliquots packaged inside your standard or proprietary delivery devices. This capability expands the realm of possibilities of reagents, cocktails and devices.
BIOLYPH's specialized equipment enables the production and packaging of LyoSpheres without jeopardizing the stable environment in which they are processed. This includes dispensing, lyophilization, post-lyophilization handling, and packaging.
BIOLYPH has demonstrated the viability of our robust and relevant technology by processing and packaging hundreds of millions of LyoSpheres.
BIOLYPH dispenses, lyophilizes, and packages our Clients' reagents to optimize their use and performance. The combination of this innovative technology and service provides our Clients with important technological capabilities and economic benefits.