Job Description

Location MV

Aliso Viejo, California, USA

Department Name

526-Quality Systems

Qualifications

1. Bachelor’s Degree required or equivalent experience.
2. A minimum of three (3) to five (5) years of quality assurance/compliance related experience in the medical device industry.
3. Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations and Application of Good Manufacturing Practices.
4. Demonstrates understanding of and adherence to Good Documentation Practices.
5. Demonstrates use of investigation techniques, root cause investigation tools, determining appropriate and effective corrective actions, and how to thoroughly document CAPAs.
6. Strong interpersonal skills, team player with good problem-solving ability, and good verbal and written communication skills.
7. Strong analytical and attention to detail skills.
8. Successful experience working independently and collaboratively, effectively and confidently in a team environment.
9. Ability to communicate effectively and partner with associates at various levels within the organization.
10. Proficient with MS Word, Excel, PowerPoint, Visio and Outlook.

Desired Qualifications

1. Lean Six Sigma, Quality, and/or Project Management related certification, preferred.
2. Knowledgeable in 21CFR Part 820, ISO13485, ISO14971, EMDR/MDD, MDSAP and CMDCAS regulations.

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

Sr Engineer, Quality Systems

Posting Country

US - United States

Salary Range

$100,000 - $125,080 (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)