Quality Technician

JOB TITLE:Quality Technician, Nova Eye Inc. (Permanent, Full Time)

DEPARTMENT &

LOCATION: Quality Dept. based at 41316 Christy Street, Fremont, CA

REPORTS TO: Quality Manager

ROLE PURPOSE:

The Quality Technician performs incoming inspection of raw materials, components and assemblies and well as in process sample inspections on production builds, verification/validation activities, QC audits of documentation, Lot release, LHR checking and product shipments and general document control activities such as those associated with ECO’s, NCMR’s and CAPA.

Has good knowledge and understanding of Good Manufacturing Practices (GMP).

KEY REQUIREMENT – GOOD ENERGY:

We are looking for someone with attention to detail and good communication skills, but mostly we are looking for someone with good energy, who is highly motivated to contribute as part of a team and to learn new skills.

RESPONSIBILITIES:

• Performs in-process inspections such as Lot release and accurately documents results
• Incoming goods inspections (IQA) against documentation such as inspection criteria/procedures/drawings.
• First article inspection of components for new and changed designs and suppliers
• Updates and assists in the development of inspection procedures
• Monitors and maintain logs for calibration and use of critical tools and equipment including CER
• Maintain quality and timely flow of production materials to work centres
• Document control including input of data and updates and maintenance of various registers and filing for Quality documents (eg ECO, NCMR, PF, CAPA)
• Follow GMP and documentation requirements
• Continually seek process improvements and make recommendations
• Generate nonconformance reports for discrepancies including material defects found during IQA
• Cross functional department communication and activities
• Stay current on all training requirements
• Perform other related Quality Department duties as instructed and requested
• Follows all Quality Management Systems policies, procedure

QUALIFICATIONS / EXPERIENCE

• High School diploma or GED required. Bachelor's degree preferred.
• 2 to 4 years medical device inspection experience or direct QA/QC inspection preferred.
• Effective verbal and written communication skills.
• PC literate with knowledge of all Microsoft Office Products.
• Experience with Mechanical and Test Equipment use, i.e. calipers, digital microscopes.
• Has good knowledge and understanding of Good Manufacturing Practices (GMP).
• knowledge of company procedures, good manufacturing procedures, strong mathematical background; mechanical knowledge; physical strength and endurance; manual dexterity; technologically savvy

COMPENSATION

Salary guidance: $30 -$34 per hour, depending on experience.

COMPANY BACKGROUND:

On 30 June 2020 Ellex Medical Lasers Limited sold the Ellex Ophthalmic Laser and Ultrasound Business to Lumibird of France and changed its name to Nova Eye Medical Limited (ASX: EYE). On 1 August 2020 Nova Eye Medical Limited acquired the Molteno glaucoma drainage device business based in New Zealand. Nova Eye Medical Limited (Nova Eye) owns three businesses in ophthalmology; 1) the Nova Eye Inc “iTrack” business based in Fremont, California that designs, manufactures and sells surgical products for treating glaucoma 2) the Nova Eye Medical “2RT” business based in Adelaide, Australia that has pre-commercial, highly prospective technology for treatment of people with early to intermediate age related macular degeneration and 3) the Molteno glaucoma drainage device based in Dunedin, New Zealand. The markets for Nova Eyes products are large, global and have high potential for growth.

**Please submit Resume with a cover letter

Job Type: Full-time

Salary: $30.00 - $34.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years
• 4 years

Schedule:

• Monday to Friday

Work setting:

• In-person

Application Question(s):

• How many years experience using mechanical and test equipment , i.e. calipers, digital microscopes, do you have?

Education:

• High school or equivalent (Required)

Experience:

• direct QA/QC inspection: 1 year (Preferred)
• medical device inspection: 2 years (Preferred)

Work Location: In person