What are the responsibilities and job description for the Inspector, Quality Control position at JENAVALVE TECHNOLOGY INC?
Job Details
Job Location: Irvine, CA
Position Type: Full Time
Education Level: 4 Year Degree
Salary Range: $25.00 - $25.00 Hourly
Description
Job Title: Inspector, Quality Control
Supervisor/Manager Title: Manager, Quality Assurance/ Director, Quality Assurance
Job Description Summary: Responsible for supporting the Quality department with quality control activities related to the manufacture of the THV within the Leeds and Irvine production facilities. To include in-process and final inspection, labelling/packaging, documentation, and environmental monitoring. The role holder will also provide routine reports and communications to provide timely updates on inspection status.
Job Responsibilities:
- Conduct routine testing on THV, to include functional, visual, and final inspection processes, along with supporting sterilization preparation.
- Perform Microbiological monitoring on ViVitro (Leeds) or BDC (Irvine) when required.
- Conduct Preventative Maintenance and calibration of the ViVitro (Leeds) or BDC (Irvine) equipment.
- Conduct audits on the in-process paperwork associated with the manufacturing process including, but not limited to: manufactured valve DHRs, Jasmine preparation and ancillary logs. Provide support to the Engineering staff by gathering data on clinical product to allow decisions to be made on functionality.
- Adhere to Quality System and record retention requirements.
- Comply with all site Health & Safety requirements.
- Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
- Inspect final packaging labels and confirm they are applied correctly per the relevant standards and Work Instructions.
- Support other areas of the business as necessary and applicable to the role.
Qualifications
Required Education and Experience:
- A-Levels, or equivalent and substantial relevant practical experience, in science related subjects are required. Bachelor’s degree in a division of Biology, Chemistry or a Biomedical related discipline is desired (Leeds).
- Minimum of 3-5 years’ experience in Quality within the medical devices or pharmaceutical industries is desirable.
- Must be familiar with 21CFR820 and ISO 13485 requirements. Hands on experience with these requirements is preferred.
- Experience assessing products for compliance and final release is desirable.
Skills and Abilities Required for This Job:
- Must be able to work effectively and collaborate within cross-functional teams.
- Must possess the ability to handle multiple tasks, with high attention to detail.
- Ability to file and organize records in a compliant, easily retrievable manner.
- Must be able to effectively articulate (verbally and in writing) results and conclusions.
- Must have good documentation skills.
- Must be able to take initiative and work autonomously with the ability to prioritize a workload.
Salary : $25
