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 have honored us with double-digit growth for the past 27 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:
- Quality Assurance
- Production Management
- Production Staff responsible for the full scope of manufacturing from Reagent Manufacturing to Packaging
- Production Scientists
- 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 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: 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.
- Proactive Quality: Use statistical analysis and Six Sigma tools/ techniques to analyze data and identify improvement opportunities.
- Validation System: Provide support across the Validation process (protocol development, protocol execution, data review, and validation report authorship).
- Supplier Management System: Survey and monitor suppliers/subcontractors and assist suppliers with quality improvement methods.
Expected Hours of Work:
- Full-time, Monday through Friday 7:00 a.m. to 4:00 p.m.
- Minimal travel required
- 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
- 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
Preferred Skills & Experience:
- Working knowledge of 21 CFR 820 and ISO 13485:2016
- Experience in the IVD Industry
- Supplier Management
- 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.
BIOLYPH, LLC is an equal opportunity employer.