- Career development with an international company where you can grow the career you dream of.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
- Execute and provide on-time completion of Quality Assurance engineering deliverables.
- Accountable for leadership, decision making, and oversight of the quality systems, including CAPA (Corrective and Preventive Action), Internal Customer Signals (ICS), and product Requests for Analysis (RFA).
- Work with key stakeholders to develop and maintain procedures and forms for the CAPA, product RFA, and ICS systems.
- Develop and lead training for CAPA, RFA, and ICS systems.
- Guide Quality Engineers and Supplier Quality Engineers with product review and analysis for CAPA, ICS, and RFA activities.
- Maintain databases and record storage for CAPA, RFA, and ICS systems.
- Process requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
- Lead meetings and communications for CAPA, RFA, and ICS system information, concerns, and updates.
- Lead CAPA, ICS, and RFA detailed data analysis, trending, and reporting.
- Publish weekly, monthly, and quarterly metrics.
- Track manufacturing related complaints in alignment with SJM goals.
- Plan ahead for various data storage needs and communicate plans clearly to prevent potential system issues.
- Seeks out information independently and able mentor/coach other members of the organization on CAPA, ICS, and RFA practices.
- Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.
- Present CAPA, ICS, and RFA System to internal and external auditors. Investigate and resolve system nonconformances and concerns (defined during internal and external audits).
- Participates in or leads in the completion of risk assessments.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- Bachelor level degree in Engineering or Technical Field
- 2+ years technical experience.
- Previous Quality assurance/engineering experience and demonstrated use of Quality tools/methodologies.
- Detailed knowledge of FDA, GMP, and ISO
- Solid communication and interpersonal skills.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance.
- Advanced degree referred.
- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Prior medical device experience.
- ASQ CQT, CQE, CQA certification.
- Six Sigma root cause analysis/problem solving training and experience preferred.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to leverage and/or engage others to accomplish projects.
- Ability to travel approximately 10%, including internationally.
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Engineer II, Quality - Pleasanton, United States - Abbott Laboratories company
Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
Job Title
Engineer II, Quality
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youll also have access to:
The Opportunity
This position works out of our Pleasanton, CA location in the Heart Failure Division. In Abbotts Heart Failure (HF) business, were developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
The Quality Engineer assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. They are responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
What Youll Work On
Required Qualifications
Preferred Qualifications
Apply Now
Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
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.
The base pay for this position is $65,900.00 $131, In specific locations, the pay range may vary from the range posted.
