Quality Engineer- Drug-Device Combinations

Overview of Job

You will perform critical functions in Quality Assurance activities which include supporting QMS and compliance, supporting various GMP/GLP activities, and assisting in qualifying our laboratory. You will perform and monitor qualifying events, including testing and reviewing batch releases, at this laboratory and at our manufacturing partner, both in Denville, NJ.

About Our Company

Rx Bandz is a growing patient-centric company that is creating the next generation of hydraulic drug delivery systems We are advancing the world of health by improving patient quality of life, enabling patients to have their life-saving medication on hand wherever and whenever needed We see our presence

in virtually every country around the world to address some of the most challenging global health issues impacting patient access to injectable medication We are a highly cross-functional group of extremely passionate employees; every perspective is encouraged and individuals driving toward solutions is expected. You will be a respected and valued member of our technology team.

Responsibilities

• Proficient understanding of medical device design controls and regulatory requirements per 21 CFR 820, ISO 13485:2016 and 21 CFR 4.
• Develops plans, procedures, protocols and reports for incoming, in-process, final inspection, and release testing activities.
• Supports QMS processes, forms, policies, work instructions and other quality system requirements.
• Supports quality events such as CAPA, Deviations, OOS/OOT, and complaints.
• Oversees GMP, GLP, and DEA quality compliance activities.
• Interprets engineering drawings and determines methods for gauging (first article dimensions and incoming inspection dimensions); performs first article inspection and other inspection requirements
• Initiates release of material to manufacturing.
• Completes batch record review.
• Manages equipment calibration and preventative maintenance activities.
• Maintains personnel training files.
• Supports Management Reviews, as required.
• Support Supplier Management Program.
• Supports internal audits.
• Support test methods, qualifications, and general validation activities.
• Assesses and evaluates statistical techniques (e.g. sampling plans) and data for analysis, as required.
• Runs lab testing, as required.
• Performs other related duties, as assigned.

Professional Experience

• Minimum of 8 years of hands-on experience with medical devices or combination products (auto-injectors or pumps).
• Experienced in FDA’s quality systems (QSIT/QMSR/ISO 13485).
• Experience writing technical documentation.
• Demonstrate proficiency in Excel or other spreadsheets, Word Spreadsheet
• Understanding of statistics. Specializes statistical software knowledge preferred such as Minitab.
• Bonus to have 21 CFR 210 and 211 plus ICH experience.
• Bonus to have ISO 19011 and or AQC auditor experience. 

Education

• Minimum Bachelor's Degree in Science or equivalent experience.