Quality System Engineer II

Irvine, California, United States

About Balt   

Our purpose is to improve the lives of 150,000 patients in 2026.   

Our story  

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices.  Our products are being used by physicians across the world, and we have 13 offices in 11 countries – and counting.  

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space. 

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.  

Why Join Balt? Join a passionate team, dedicated to making a difference.   

  1. Working at Balt means giving meaning to your work! Pride is a strong part of our identity.   
  1. We are a close-knit team, with strong mission, vision and values that guide our day-to-day.   
  1. Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.   
  1. No matter the country, we take care of you.   

Would you like to be part of our story? Don't hesitate, come and join us! 

About this opportunity – Quality System Engineer II 

Description

The Quality System Quality Engineer II will be responsible for supporting Balt USA’s quality system including, but not limited to, coordination of NCMRs and CAPAs, supporting audit execution, and supporting document control and training compliance. 
This Quality Engineer will be expected to work directly with different functions while receiving support and guidance from other engineering staff and the QS Supervisor to complete tasks. 
This position will have the responsibility to support and continuously improve current QS processes through technical and process innovation for the manufacture of neurovascular medical devices.


Job Responsibilities 
Knowledge of quality systems for medical device manufacturing and requirements for manufacturing, inspection and testing. 
Plans, documents (protocol and reporting) product/process validations. 
Participate in audit activities. 
Initiate and/or verifies corrective and preventative actions resulting from NCMRs, CAPAs, audit findings and customer complaints. 
May help with qualifications for manufacturing transfer activities, including new or changed materials and processes, equipment IQ/OQ/PQ/PPQ. 
Identify, evaluate, and supports software validation activities. 
Lead meetings for process improvement and problem solving. 
Communicate with process stakeholders to address quality concerns and resolves issues. 
Maintain and develop processes and procedures by writing standard work instructions for quality system enhancements supporting production and quality controls. 
Have a clear understanding of FDA’s QMSR, ISO 13485 requirements, EU medical device regulation, and a good understanding in the application of statistics to process analysis and improvement. 

Qualification Requirements
Bachelor’s degree required, preferably in an engineering or science discipline. 
3+ years as an Engineer in a related field. 
Medical device or pharmaceutical experience. 
Data analysis skill set. 
ASQ certification a plus.

Highly Desired Qualifications 
Class II and III implantable medical device experience with focus on neurovascular devices. 
Strong communication skills working with multiple departments. 
A demonstrated ability to plan and run projects. 

Skills 
Keen attention to detail when reviewing documentation and processes. 
Solid technical writing ability. 
Be able to work independently and cross functionally as part of a team. 
Comfortable communicating with a wide range of people from production, regulatory, management, suppliers, and other functions. 
General understanding of risk management, including design, use, and process FMEAs as well as a basic understanding of severity, occurrence, and risk mitigation and their impact on product and process controls. 
General understanding of process validation (OQ/PQ) and ability to develop test protocols/report to meet FDA and ISO requirements for class II and class III devices. 
Understanding of CAPA process and root cause analysis tools and how to use them. 
Ability to develop manufacturing documentation (e.g., manufacturing procedures, engineering drawings, BOM, work orders). 
General familiarity with design control requirements and V&V testing for new product designs. 
Effectiveness with lab equipment, assembly tools, and measurement devices. 
Basic understanding of statistical analysis techniques for identifying process capability and equivalence testing. 
Knowledge of computer applications (i.e.: Microsoft Project, Word, Excel, PowerPoint, Windows, Visio, etc.) required. 


Work Environment 
Working conditions are normal for an office environment. 
Extended computer usage.  
Standard PPE gowning requirement for cleanroom activities is required. 
Moderate lifting 
Extended periods of walking or standing

 

More information please go to www.baltgroup.com  

 

Please be aware of a current job offer scam perpetrated through the use of the internet. The scammers frequently misappropriate and use a company’s log and photos to give the appearance of legitimacy. The scam preys upon those seeking employment and uses false and fraudulent offers of employment with employers, such as Balt Inc to steal from the victims. Balt believes that one of the best ways to put a stop to this scam is to make sure you are aware of it. Balt’s job recruitment process involves live communication: in person, telephone, and/or video interviews in most cases.  

 

#LI-FW1 

#LI-Remote

Pay Range

$90,000 - $100,000 USD

Create a Job Alert

Interested in building your career at BALT Group ? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV

Accepted file types: pdf, doc, docx, txt, rtf

Cover Letter

Accepted file types: pdf, doc, docx, txt, rtf

Select...

Your personal data collected by BALT SAS is subject to automatic processing for the strict purpose of processing your application and assessing the suitability of your profile for the position offered by BALT SAS or its affiliates. This processing is carried out in the legitimate interest of BALT SAS. Your personal data will be kept for a maximum of 24 months. During this period, you may be contacted at any time by BALT SAS or its affiliates. The recipients of your data are the Human Resources Department of BALT SAS and any other person specifically authorised to access them in the performance of their duties. As a data subject, please note that you have the following rights with regard to your data: right of access, right of rectification, right to erasure (right to be forgotten), right to restriction, right to portability. You may also, for reasons relating to your particular situation, object to the processing of your data. You may exercise your rights by writing to BALT data protection team at the following email address: dataprotection@baltgroup.com or by post at 10 rue de la croix vigneron, 95160 Montmorency, France,  providing proof of your identity. Subject to a breach of the above provisions, you have the right to lodge a complaint with your competent supervisory authority.

 

Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in BALT Group ’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.