1st shift Quality Inspector

Job Description

Job Description

Monday-Friday 6:45 AM-3:05 PM

Summary/objective
Maintains quality system requirements for medical device manufacturer according to ISO 13485,
FDA 21 CFR 820, and Canadian Medical Devices Regulations (SOR/98-282). Tests and inspects products at various stages of the production process to maintain the quality and reliability of product.

Essential functions

• Candidate needs to have exemplary attention to detail, strong problem-solving skills, and ability to effectively interact with multiple facility functional areas.

• Performs assigned primary duties plus incoming raw material inspections and other areas requiring inspection according to internal procedures.

• Collects statistical data and measures against product specifications to improve ongoing quality control and procedures.

• Maintains facility quality objectives and coordinates implementation with functional areas such as Production, Engineering, Facilities Management, and Quality Assurance.

• Reviews and confirms engineering drawings, schematic diagrams, work orders, and applicable lot numbers against inspected product.

• Selects products for quality inspection at specified stages of production and test products for a variety of quality attributes including visual, dimensional, and functional characteristics.

• Supports 5S, Lean Six Sigma, and continuous improvement projects within the facility.

Competencies

• Must have experience with measurement instruments such as Optical Comparator, Micrometer, Caliper, Go/No Go Gauges

• Must have experience with ASQ/ANSI Zl.4 sampling plans.

• Must have supported CAPA, NCR, Customer Complaint investigation, root cause analysis, and corrective/preventive action implementation.

Required education and experience
[Indicate requirements that are job-related and consistent with business necessity]

• High School Diploma or Equivalent.

• 1-year minimum experience in Good Manufacturing Practice (GMP) environment with ISO 13485 or ISO 9001 facility certification and strong knowledge base of quality inspections.

Preferred Education and experience
[Indicate requirements that are job-related and consistent with business necessity]

• ASQ training such as a Certified Quality Technician preparation course is preferred.

• Basic proficiency operating the Keyence, including using pre-written programs, is preferred

Physical demands & Travel required

• While performing the duties of this job, the employee is regularly required to sit; use hands to handle, or feel objects, tools, or controls; and talk or hear.

• The employee frequently is required to stand.

• The employee is occasionally required to reach with hands and arms.

• The employee must frequently lift and/or move up to 25 pounds.

• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

• While performing the duties of this job, the employee occasionally works near machinery and moving mechanical parts.

• The noise level in the work environment is usually quiet.

Pay Details: $19.00 to $21.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.