The Quality Engineer (QE) is responsible for the engineering (quality/manufacturing), facility and project management activities in the San Antonio manufacturing facility. This individual will be responsible for all qualifications, validations, process optimization, equipment maintenance, and facility maintenance. The QE will ensure full compliance to 21 CFR Part 1271, AATB, ISO 13485, State Licensure Requirements and Stability Operating Procedures.
Write equipment qualification protocols, execute qualifications and write qualification reports.
Write process validation protocols, execute validations as applicable and write validation reports.
Write test method validation protocols, execute test method validations and write test method validation reports.
Maintain facility equipment, assign equipment numbers and maintain accurate equipment list.
Ensure all preventative maintenance and calibrations are performed on all equipment per manufacturer’s requirements.
Perform preventative maintenance and calibration on equipment.
Facilitate and schedule all equipment service with qualified vendors.
Write Equipment Operation and Maintenance SOPs.
Write process SOPs and forms.
Perform facility maintenance including repairs and scheduling service.
Analyze and evaluate manufacturing and quality control processes for optimization and efficiency.
Provide input and assist in the development of new products and R & D activities.
Perform internal audits and supplier audits as needed.
Participate on Risk Analysis teams for Risk Management.
Investigate CAPAs/NCMRs and Complaints as needed.
Analyze metrics and prepare trends, graphs and reports for executive management.
Create and maintain appropriate databases for engineering and project management activities.
Perform any other related duties as assigned and needed.
REQUIRED SKILLS & KNOWLEDGE
BS degree in a scientific discipline (Chemistry, Biology, Physics, Bio-Medical Engineering/Chemical Engineering, etc.), advanced degree, Masters Degree preferred.
At least 2 years experience in a tissue bank, medical device or pharmaceutical company.
Knowledge of tissue bank manufacturing and compliance procedures
Knowledge of AATB Standards, 21 CFR 1271 (GTP) and 21 CFR 820 (GMP) regulations.
Knowledge of ISO 13485 and ISO 14971 standards.
Knowledge of project management principles.
Budget development and oversight experience.
Experienced and proficient with Excel and Word programs.
Organized, attention to detail and maintain appropriate analytical skills.
Strong communication skills, both written and verbal.
Able to lift 40 lbs.
Additional Salary Information: Salary negotiable; Commensurate with experience
Stability Biologics, LLC is a leading provider of high-quality human tissue and synthetic products to surgeons, facilities and distributors. Our national tissue network provides access to a large volume of safe, high-quality tissue for transplant or research. Stability Biologics is committed to the principles of quality, consistency, innovation and safety.
Working at Stability Biologics is rew...arding on many levels. You will take great pride in providing extraordinarily valuable services to patients across the country, and enjoy the satisfaction that comes from working for an employer who understands the balance between work and private life.