Job Application for Senior Quality Engineer at Element Biosciences

At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.

We are seeking an experienced Senior Quality Engineer who will play a pivotal role in maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices (Class I-II). Experience with developing strong working relationships with both internal and external customers to influence and enable an effective Quality Culture is a must. This role will report to the Manager, Quality Engineering and will be a San Diego based role.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Essential Functions and Responsibilities:

Spearhead development and continuous improvement of QMS processes, including but not limited to internal audits, design and process / equipment / software validation, management review
Lead / conduct internal audits and prepare / coach teams on audit best practices to drive towards compliance
Interpret regulations and requirements to lead efforts related to Risk Management, Verification & Validation, Design History File (DHF), Design Master Records (DMR), Device History Records (DHR)
Support activities related to Non-Conformance Reports (NCRs), deviations, complaint investigations, change management to ensure QMS requirements are being met
As needed support supplier management activities including onboarding/qualification, quality investigations, supplier business reviews, and ongoing monitoring

Education and Experience:

Bachelors degree in Engineering, Biology, or related science field (an equivalent combination of experience and education may be considered)
A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry
Experience with ISO13485, ISO 14971, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred
Experience leading internal and external audits is strongly preferred
Experience with wide range of validation including design, process, equipment, software is strongly preferred
Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
Strong interpersonal skills with the ability to collaborate closely with suppliers and with internal stakeholders of varying levels to drive Quality System improvements
Demonstrates an ability to work independently and as part of a team
Self-motivated and able to organize and prioritize multiple tasks
Strong inclination and passion for continuous improvement
Strong analytical skills, reporting, and data analysis are strongly preferred
Experience working with electronic Quality Management System and manufacturing-related business systems, like ERP and MES, is preferred
ISO13485 Lead Auditor certification and ASQ CQE certification is a plus

Physical Requirements:

Frequently moves boxes weighing up to 20 pounds

Location:

San Diego (on-site)

Travel:

Domestic travel up to 10%

Job Type:

Full-time/Exempt

Base Compensation Pay Range:

$104,600 - $137,400

In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off.

Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience.

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Create a Job Alert

Interested in building your career at Element Biosciences? Get future opportunities sent straight to your email.

First Name

Last Name

Country

Phone

Resume/CV

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

Cover Letter

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

LinkedIn Profile

Website

What is your preferred name?

Are you over the age of 18?

Select...

What is your current location?

Are you willing to relocate if needed?

Select...

As of today’s date, are you legally authorized to work in the country in which the position is located?

Select...

If you are a foreign national, will you now or in the future require sponsorship for employment visa status?

Select...

If you answered, "yes" to the previous question, please provide additional context below.

Do you have any contractual restrictions on your employment?

Select...

Please provide your date of availability.

When you apply to a job on this site, the personal data contained in your application will be collected by Element Biosciences, Inc., (“Controller”), which is located at 10055 Barnes Canyon Road, Suite 100, San Diego, CA 92121. Controller’s team responsible for data privacy can be contacted at Privacy@elembio.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. Because the European Union Commission has determined that United States data privacy laws do not ensure an adequate level of protection for personal data collected from EU data subjects, the transfer will be subject to appropriate additional safeguards. If you can have any questions, please contact us at privacy@elembio.com. Your personal data will be retained by Controller for two (2) years for the purpose of Controller evaluating your application for employment. Your consent will be requested prior to Controller retaining the data longer than two (2) years. Under the GDPR, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability. In addition, you may lodge a complaint with an EU supervisory authority.

Select...

GDPR Notification

I certify that the information I have provided to Element Biosciences on this application is correct to the best of my knowledge and I understand that any falsifications, misrepresentations, and/or omissions may result in my disqualification for consideration of employment or, if subsequently employed, my dismissal.

Select...

If you have any additional requirements or would like to elaborate on any of your responses above, please use the text box below.

From our Hiring Manager: If a team is planning to make a major change to on-market product, what is the best way to capture approval on that change prior to execution? The method needs to be effective and low barrier for the teams to follow.

From our Hiring Manager: Describe how you would lead internal audit training for Element (based on your knowledge of the company). Assume that there are employees of varying prior experience to audits and varying exposure to the QMS.

From our Hiring Manager: If you are tasked to build a risk management file for AVITI retrospectively, outline the strategy you would follow to ensure speedy deployment. Include the projected duration and resources you would need.

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.

How would you describe your gender identity? (mark all that apply)

Select...

How would you describe your racial/ethnic background? (mark all that apply)

Select...

How would you describe your sexual orientation? (mark all that apply)

Select...

Do you identify as transgender?

Select...

Do you have a disability or chronic condition (physical, visual, auditory, cognitive, mental, emotional, or other) that substantially limits one or more of your major life activities, including mobility, communication (seeing, hearing, speaking), and learning?

Select...

Are you a veteran or active member of the United States Armed Forces?

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 Element Biosciences’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Select...

Are you Hispanic/Latino?

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.

Veteran Status

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

Disability Status

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.

Senior Quality Engineer

Apply for this job

U.S. Standard Demographic Questions

Voluntary Self-Identification

Voluntary Self-Identification of Disability