Inspector II, In-Process & Finished Product, QC (2nd Shift)

14213BR

Title:

Inspector II, In-Process & Finished Product, QC (2nd Shift)

Job Description:

Proficient in performing all duties and responsibilities of Inspector I, In-Process & Finished Product, QC and assist the QC Lead in reviewing device history record to assure compliance. Perform quality control inspections on products at various stages of production from sub-assemblies to final assemblies to assure quality and conformance to specifications and procedural requirements. Job duties:

• Conduct visual/dimensional QC inspection and/or testing of incoming materials, in-process materials, sub-assemblies, labeling, and final inspection of finished goods while utilizing visual inspection systems and other inspection tools per inspection requirements to ensure conformance to Quality Specification and procedural requirements.

• Accurately measure and record data on data collection forms.

• Read and understand Product Drawings and specification dimensions.

• Input data into online tracking software.

• Provide feedback to Quality and/or Manufacturing on quality issues.

• Record, maintain, and communicate all nonconformance to relevant parties involved to ensure timely Corrective Action completion.

• Coordinate with production associates to perform in-process, finished product, and final documentation reviews to release finished goods.

• Maintain a safe and clean working environment following 5S principles.

• Train other inspectors on QSs, TMs, and procedures as required.

• Consistently review in-process batch documentation to ensure real-time compliance with product specifications, Good Documentation Practices, SOPs, and cGMPs.

• Coordinate calibration of equipment/tools as required and maintain calibration records.

• Assist QC Lead in reviewing, closing, scanning, and uploading Build Records into the network drive.

• Must be able to work overtime when needed.

• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

• Perform additional duties as assigned.

Auto req ID:

14213BR

Location MV:

Aliso Viejo, California, USA

Department Name:

311-Product Inspection Quality Assurance

Qualifications:

1. High school diploma or equivalent.

2. Minimum three (3) years of relevant experience in medical device manufacturing or inspection.

3. Strong reading, verbal, and written communication skills.

Desired Qualifications

1. Demonstrated knowledge of inspection techniques, understanding and reading technical documentation including product drawings.

2. Interpersonal savvy, able to clearly and effectively communicate (read, write, and speak in English).

3. Detail oriented.

4. Knowledge of cGMP, GDP, QMS, and/or ISO regulations.

5. Knowledge of basic measuring techniques including scales, rulers, calipers, micrometers, etc.

6. Knowledge of computer software, including MS Word, Excel, Outlook, Teams, etc.

7. Ability to work in a fast-paced environment and to balance and prioritize workload to support production’s schedule.

8. Ability to work with a culturally diverse work population.

9. Previous experience with video inspection equipment and other inspection tools.

Physical

• Extended periods of microscope and computer use.

• Extended periods of sitting, walking, or standing.

• Twisting, bending (e.g., back, arms, legs, etc.).

• Repetitive motion with arms, hands, wrists, and fingers: gripping, grasping, twisting, pulling, etc.

• Ability to work with various chemicals.

• Extended periods of working in a Controlled Environmental Area (clean room), following proper gowning in/out procedures and wearing Personal Protective Equipment including a jumpsuit, gloves, hairnet, shoe covers, and surgical mask.

• Light lifting, up to 25 lbs.

• May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs).

EEO

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

Fair Chance Ordinance

If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

External-Facing Title:

Inspector II, In-Process & Finished Product, QC (2nd Shift)

Posting Country:

US - United States

Salary Range:

$18.93/Hour - $24.84/Hour (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.