Quality Engineer II
Quality Engineer II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 86700 - 173300
1 Vacancy
Job Description
JOB DESCRIPTION:
Job Title
Quality Engineer II
Working at Abbott
At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life. Youll also have access to:
Career development with an international company where you can grow the career you dream of.
Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.
An excellent retirement savings plan with a high employer contribution
Tuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors degree.
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity working mothers female executives and scientists.
The Opportunity
This position works out of our Alameda CA office in the Lingo Division. Working on Lingo you will help build a next-generation technology that enables individuals to make decisions about how to improve energy lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott a company with a rich history of healthcare innovation. This position is responsible for activities related to design control; qualification; specification and corrective and preventative action of medical devices including software as a medical device (SaMD) in-vitro diagnostic devices consumer devices and accessories.
What Youll Work On
Lead/support design planning efforts to include heading cross-functional teams; establishing deliverables and tracking completion for complex projects
Lead/support complex investigations and CAPA activities
Drives alignment in cross functional meetings acting as QA representative on new and on-market product design projects to ensure compliance with the internal design control process and external standards and regulations.
Contributes to the planning and execution of risk management for new products and supports the development of the risk management file.
Reviews and approves engineering changes in a timely manner.
Collaborates with R&D and Marketing to support mobile app deployment activities (for Software as a Medical Device projects).
Drives alignment during cross functional review and approval of impact assessments root-cause analysis investigation and resolution activities.
Reviews and approves batch records and other release documentation for products used in design verification/validation testing clinical investigations research use and demonstration purposes.
Reviews and approves batch records for release of commercial products and documentation for approval for shipment.
Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures.
Collects organizes and monitors information related to quality and process improvement.
Participates in internal & external audits and ensures audit responses are submitted in a timely manner.
Required Qualifications
Bachelors Degree or equivalent experience in Engineering Technical Field Life Science or
closely related discipline.Minimum 5 years in applicable technical/engineering experience and demonstrated use of Quality tools/methodologies.
Minimum 2 years experience in regulated environment such as medical devices or pharmaceutical products.
Knowledge of medical device standards including FDA QSR ISO 13485 ISOCFR Part 11 and IEC 62304.
Excellent oral and written communication skills.
Preferred Qualifications
Prior design control experience preferred.
Knowledge of Jira Confluence and/or other software development tools is a plus.
ASQ CQE or CSQE Certifications a plus.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews.
i
The base pay for this position is
$86700.00 $173300.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
LNGO Lingo
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 5 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol:
Employment Type
Full-Time
Key Skills
Similar Jobs
Dr. Job is an online platform that connects employers with skilled job seekers, facilitating the search for job opportunities and top talent. Established in 2015. Dr. Job Pro has emerged as the world premier job portal, attracting thousands of job seekers every day from all over the world.
Follow Dr.Job
Dr Job FZ LLC. 2025 © All Rights Reserved