Quality Engineer II - job 1 of 3

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. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical 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 bachelor’s 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 You’ll 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, ISO 14971, 21 CFR 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.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

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.

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