New

Quality Engineer

USA - South San Francisco, CA

The Quality Engineer is responsible for providing ongoing product quality engineering support throughout the product life cycle for multiple product platforms.  The individual is responsible for ensuring compliance to 21 CFR 820, ISO 13485, EU IVDR and other applicable international / local regulatory requirements.

What You’ll Be Doing

  • Conduct comprehensive reviews of batch records to ensure compliance with cGMPs and company procedures.
  • Identify and investigate potential discrepancies or anomalies in batch records.
  • Perform statistical analyses on batch data to assess product quality and identify trends.
  • Prepare and maintain statistical reports to document findings and support quality decision-making.
  • Contribute to the development and implementation of quality control procedures.
  • Participate in product release activities, including reviewing release documentation and providing quality assurance sign-off.
  • Stay up-to-date on the latest cGMP regulations and quality engineering practices.
  • Provide quality support to quality control, field application scientists, and customer support
  • Provide support to design and development, engineering, and manufacturing for functions for validation planning and transfer activities.
  • Collaborates with Quality Management to support change controls activities (e.g. engineering, process, raw materials, etc.) deviation management, and document change management.
  • Ensures adequacy of complaint, non-conformances and CAPA records, investigations, and corrective/preventive actions.
  • Represents QA and QC on the incident management committee in efficiently processing customer incident and identifying trends to help improve product quality.
  • Provides quality support in the assessment and qualification of new supplier materials such as component specifications and inspection standards.
  • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change requests.
  • Provide quality consultation to end users and process owners with regards to data collection, analysis, and creation of validation reports.
  • Become familiar with the applicable technology to facility ate participation in technical discussions and risk-based decision making.
  • Review verification and validation reports and identify gaps for compliance to internal quality requirements.
  • Coordinate issue resolution using risk-based approach.
  • Identify areas and opportunities to improve quality system processes and product issues.
  • Ensure product development and validation programs meet internal quality programs.
  • Trend, analyze, and report on quality data in order to improve product and processes.
  • Provide management with status updates on assigned responsibilities and goals.
  • Escalate issues in a timely fashion.
  • Own and/or coordinate CAPAs, Complaints, and NCRs specific to product quality issues.
  • Effectively influences and trains employees (as required).
  • Maintains strong communication network with peers.
  • Demonstrated effective knowledge of use of various computer systems.
  • Additional responsibilities as assigned.
  • Ability to travel 10%
  • Follow regulatory and ISO 13485 requirements

 

What You’ll Bring to the Team

  • Bachelor’s degree in a scientific or engineering discipline, plus a minimum 3 years of work experience in quality engineering role; or equivalent work required.
  • Familiarity with regulatory requirements for IVD Products, ISO 13485, 21CFR820, IVDR, applicable experience in medical device, or biotech manufacturing and a thorough knowledge and understanding of cGMP.
  • Experience in Pharmaceutical, NGS, and/or Molecular Diagnostics a plus.
  • Highly organized, with ability to prioritize own tasks and ability to work effectively virtually in conducting internal and external business.
  • Strong interpersonal skills.
  • Excellent oral and written communication skills, including the ability to articulate clear messages from complex data/information.
  • Ability to work across functions throughout a global organization at all levels.
The base cash compensation for this California-based role is below. In addition to base salary, this role is eligible for bonus, equity, and a generous benefits package. Final compensation amounts are determined by multiple factors, including candidate skill, experience, expertise, and location and may vary from the amount listed above. Compensation may be different in other locations.

San Francisco Bay Area Pay Range

$90,000 - $115,000 USD

Create a Job Alert

Interested in building your career at Twist Bioscience? 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

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 Twist Bioscience’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.