Quality Technician II

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 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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. You will have access to:

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

• Health Insurance (starting on Day 1 of employment), Savings Plan (401K) with company match, Life insurance for you and your spouse/children, Short Term Disability, Long Term Disability, Education Assistance, Employee Assistance Program, Vacation, Sick, Personal Days.

• 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.

What You’ll Do​

This position works out of our Arecibo location in the CRM division at 2nd shift.

• Responsible to devise quality control procedures and methods, implement quality control techniques, test and inspect products, and compile and evaluate statistical data to monitor quality levels.

• Establish tolerances or acceptable deviations of components and products.

• Use engineering blueprints, drawings and specifications to complete accurate measurement and inspection of parts for dimensions, performance and mechanical, electrical and chemical properties.

• Train others on processes and procedures impacting component and/or product quality.

• Complete paperwork timely and accurately. prepare charts and write summaries about how well product conforms to existing standards.

• Participate on cross-functional teams. offer suggestions to others on how to modify existing process or procedures to improve quality.

• Responsible for compliance with applicable regulations and requirements, as well as Corporate and Divisional policies and procedures.

• Responsible for implementing and maintaining the effectiveness of the Quality System.

• Monitors manufacturing non conformances and assist in the investigation of product issues and the gathering of information during investigations to address the nonconformance root cause.

• Assist in the preparation of reports for line defects trend analysis, process monitoring data (SPC) and quality summaries. • Prepare and Execute Quality related validations (IQ, OQ, PQ, PPQ, IMV, TMV etc.)

• Development of processing tools that addresses non conformances root causes derived from investigations.

• Coordinates and perform applicable testing. Review and approves, as required, routine test results. Executes investigations on Quality System alarms/alerts/escalations/out of specifications/etc.

• May become NCMR/CAPA certified to complete nonconformance reports or corrective/preventive investigations.

• Other duties as assigned.

Required Qualifications​

Associate's degree in engineering, Engineering Technology fields (Electronics Tech, Mechanical Tech, Instrumentation Tech, etc.)

Minimum 6 years of related work experience in Medical Device industry or equivalent, where compliance to GMP and regulations (such as FDA/ISO 13485) is required.

•Intermediate knowledge in NCMR/CAPA (i.e., investigations) process and problem solving tools, validations (IQ, OQ, PQ) and statistical concepts (distributions, normality, control charts, cpk, SPC, sampling, C&R, etc.)

•Capable of managing statistical software with little supervision (Minitab, JMP, VSPC, IQS, etc.)

•Excellent computer skills and knowledge on Microsoft Office tools (Word, Excel, and Power Point).

•Excellent communication skills in Spanish (written/verbal) and English (written) •Must have a quality mindset.

•Applies extensive knowledge of advanced technical concepts and GMP practices, and a complete understanding of product or systems fundamentals in a functional area and working knowledge of other related disciplines. •Utilizes/interprets advanced numerical and statistical data and computer software programs to present documentation and analysis and resolve complex problems.

•Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with internal procedures and governmental regulations.

Preferred:

•Knowledge in Access, Visio, Project and PowerBI

•Advanced knowledge in statistical concepts

•Fluent in English (verbal)

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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The base pay for this position is $16.21 – $32.39 per hour. In specific locations, the pay range may vary from the range posted.