Quality Assurance Specialist

Quality Assurance

Quality Assurance is a member of the Professional Team. As a Class 1 Medical Device, Quality Assurance oversees the numerous quality systems mandated by FDA regulations. He/she monitors the compliance of the Quality System against the laws and regulations.

Qualifications:

He/she needs to be technically competent in his/her area of expertise

He/she needs to be demanding but realistic in his/her expectations of team members

He/she has demonstrated the ability to grow with the expanding responsibilities of the job

He/she must be steady and determined to reach extraordinary goals

Educational Requirements:

All employees of Oxyrase Inc. are required to complete a Safety Course and a Microbiology Course as assigned by your manager within 6 months of your start date. All educational requirements are covered by Oxyrase Inc. Coursework requirements may be met through previously documented training.

Specific Qualifications:

Associates degree in biology, Life Science, or other related field, demonstrated knowledge and related experience in Quality Systems.

Knowledge of cGMP, GLP, QMS, ISO, FDA requirements for medical device manufacturing

Ability to address product/process deviations and complaints

Understands Regulatory and Production constraints inherent to medical device manufacturing

Experience working as a Microbiology Laboratory Lab Technician is a big plus.

General Responsibilities:

Host and assist with all regulatory audits and requests.

Final release of all products from the facility. 

Manage and perform all calibrations of identified equipment.

Release of all raw materials used in the manufacturing processes.

Responsible for the document control and change systems.

Ability to maintain a favorable and collaborative environment within the site and personnel

Ability to proactively manage multiple projects and prioritize to organize time effectively

Excellent interpersonal effectiveness, written and verbal communication skills

Work independently, manage time efficiently, and communicate clearly