Sr Technician, Quality (Product Evaluation Lab)

Terumo Neuro; Aliso Viejo (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Terumo Neuro in the United States is seeking a Sr Technician, Quality (Product Evaluation Lab) to support QA activities related to the development and manufacture of medical devices.

You will collaborate with engineers to investigate product reliability and address quality issues, document findings from post-market complaints, and assist with testing, CAPA projects, and validation efforts in a GMP environment.

Qualifications

• High school diploma or equivalent.
• Minimum three (3) years of related work experience.
• Good written and verbal communication skills.
• Ability to read, write, and speak in English.
• Ability to read procedures and drawings.
• Basic computer skills including MS Word, Excel, Teams, Outlook.
• Knowledge of GMP and lab/ manufacturing practices.

Responsibilities

• Support QA activities related to development and manufacture of medical devices.
• Investigate and address post-market product quality issues and customer complaints.
• Assist engineers with investigation of product and process quality issues.
• Assist with product testing, test method development and validation.
• Help with calibration, CAPA, nonconformance reports, internal audits.
• Input received returns data and manage decontamination workflow.
• Operate X-Ray Machine (certification required).
• Contribute to process improvement in complaint handling.
• Perform additional duties as assigned.

Skills

Written and verbal communication

English literacy

Education

High School Diploma or equivalent

Tools

MS Word

MS Excel

Teams

Outlook

Job description

14271BR

Job Description:

Support the quality assurance activities related to development and manufacture of medical devices. Work with engineers to investigate and address various product reliability and quality issues. Job duties:

• Product evaluation, investigation, and documentation of post-market product quality issues relating to customer complaints.

• Investigation and evaluation of products relating to reportable complaints (e.g. MDR, Vigilance, etc.), including documentation.

• Assist engineers with investigation of product and process quality issues.

• Assist engineers with product testing and test method development and validation.

• Assist with activities related to equipment calibration, corrective/preventive actions, nonconformance reports, internal audits, and CAPA projects.

• Assist Lab Coordinator with receiving, decontaminate product returns in-house, and input into database.

• Operate X-Ray Machine (certification required).

• General complaint handling and investigation process improvement.

• Perform additional duties as assigned.

Qualifications:

1. High school diploma or equivalent.

2. Minimum three (3) years of related work experience.

3. Good written and verbal communication skills.

4. Ability to read, write, and speak in English.

5. Ability to read and follow test procedures.

6. Ability to read manufacturing procedures and product drawings.

7. Ability to read and understand technical documentation.

8. Basic computer skills including MS Word, Excel, Teams, Outlook, etc.

9. Good laboratory or manufacturing practices and ability to follow required safety procedures.

Desired Qualifications

1. Knowledge of and experience with the MicroVention product portfolio.

2. Proficient in technical writing.

3. Knowledge of medical device manufacturing and quality.

4. Experience with medical device testing and product knowledge (e.g., multi-meter, hand tools, etc.).

5. Windchill navigation.

<

6. SAP knowledge and/or experience.

7. Experience in the medical device industry.

Physical

• Extended periods of microscope and computer use.

• Extended periods of sitting, walking, or standing.

• Moderate lifting, up to 50 lbs.

• Manual dexterity and hand-eye coordination to complete required tasks.

• Gowning may be required in controlled environments. Personal Protective Equipment use, including safety glasses and gloves, required for certain tasks or areas.

• May work with machinery and chemicals, requiring strict adherence to safety protocols.

• 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.

Posting Country:

US - United States

Title:

Sr Technician, Quality (Product Evaluation Lab)

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.