Sr Quality Engineer – Supplier Quality

 

The Sr Quality Engineer will provide expertise and support compliance of Supplier Controls with applicable Regulations and Standards (ISO 13485:2016, IVDR, FDA 21 CFR 820, etc.). They will lead Supplier Quality Team Meetings, Internal CAPAs (related to supplier controls), Supplier Incidents resolutions, SCARs, and Supplier Audits.  They will support the Internal Audit Program.  They will Interact with individuals at multiple levels within all functional departments, including Quality Assurance Engineering, Software Quality Assurance, R&D, and Marketing.

 

What You’ll Be Doing

  • Own Supplier Quality processes including Supplier Controls, Global Supplier Selection, Evaluation and Re-Evaluations, SCAR Processes and Supplier Monitoring as a Corporate Business Process Owner.
  • Run weekly Supplier Quality Team meetings (High Level and Supplier Issues) with cross functional stakeholders presenting the status of Supplier Quality health with metrics on Audits, SCARs, Supplier nonconformances and ASL.
  • Collaborate with Regulatory Affairs/Quality Systems team and Periodically analyze and review Supplier Controls process to stay in compliance with latest applicable Regulations and Standards.
  • Lead internal CAPAs related to Supplier Controls.
  • Lead high visibility SCARs and Key Supplier Audits (Evaluations and Re-Evaluations) as a Lead Auditor.
  • Support Internal and External Audits (FDA, EUIVDR, ISO, Customer, etc.) representing Supplier Quality in Audits Front rooms.
  • Lead Projects as a Project Manager to improve Supplier Controls Processes to improve efficiency and compliance.
  • Be a technical custodian of Supplier Data Monitoring and Analysis. Analyze and prepare data for Supplier Data Monitoring and Analysis.  Analyze and prepare data for Supplier Quality Team meetings and monitor data for accuracy.
  • Review and Approve Product SCARs and be the lead for SCAR Review Boards
  • Support Purchasing (category buyers/managers) on Quality Management System elements of Supplier Agreement negotiations with Suppliers.
  • Assist in scheduling Internal Audits and managing the Internal Audit Schedule.
  • Coordinate and participate in Internal Audits in addition to Supplier Audits.
  • Ensure the Quality Systems group is appropriately staffed to ensure timely completion of responsibilities.
  • May lead or manage team members.
  • Follow regulatory and ISO 13485 requirements

What You’ll Bring to the Team

  • Bachelor’s in Chemistry, Biochemistry, Molecular Biology, Biomedical Engineering, Drug Development & Product Management, or a related scientific or engineering discipline. 
  • 5 years of QA experience working in drug or medical-device regulated industry ​
  • Knowledge of supplier qualification activities.
  • Knowledge of good manufacturing processes. 
  • ISO 13485:2016 Lead Auditor Certification 
  • Experience leading and mentoring team members. 
  • Experience making trade-off decisions while balancing compliance and business impact. 
  • Experience working in cross functional teams. 
  • Experience implementing practical Quality System and Compliance solutions. 

 

 

About Twist Bioscience

Twist Bioscience synthesizes genes from scratch, known as “writing” DNA. Just as children learn to both read and write, the next phase of development for the genomics revolution is the ability to write DNA.

At Twist Bioscience, we work in service of people who are changing the world for the better. In fields such as health care, agriculture, industrial chemicals and data storage, our unique silicon-based DNA Synthesis Platform provides precision at a scale that is otherwise unavailable to our customers.

Twist Bioscience Corporation is an Equal Opportunity Employer. Twist Bioscience Corporation provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, genetic characteristics, or any other category protected by law.

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
$95,000$130,000 USD

Apply for this Job

* Required

resume chosen  
(File types: pdf, doc, docx, txt, rtf)
cover_letter chosen  
(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.

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.


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

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.


Enter the verification code sent to to confirm you are not a robot, then submit your application.

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.