Quality Inspector II

abbott; Minnetonka (MN); On-site; USD 29,000 - 58,000; Full time

Benefits offered by this job

Health coverage in HIP PPO plan

Excellent retirement savings with high

Tuition reimbursement

FreeU education benefit

Career development in an international

Recognition as a great place to work

Diversity and inclusion programs

Job summary

Abbott in Minnetonka, MN is seeking a Quality Inspector II to support quality engineering in new product development, manufacturing and services. This onsite role includes performing inspections, documenting nonconformances, and helping maintain calibration and test equipment.

You will work with engineers and quality teams to ensure compliance with FDA regulations and ISO 13485, applying blueprints, sampling techniques and Gage R&R methodologies.

Qualifications

• Associates degree or completion of a 2-year technical program or equivalent experience.
• 2-4 years' experience in quality or related field.
• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gauges and fixture design.
• Training in blueprint reading and sampling techniques.

Responsibilities

• Perform first article incoming inspection of purchased components and inspection of production operations with documentation.
• Document nonconformances as appropriate.
• Monitor and calibrate/test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, and document test results.
• Assist with Gage R&R studies.
• Assist with selecting, installing and programming precision measuring equipment.
• Create and maintain control plans for products and processes.
• Support QMS/EMS and regulatory compliance programs.

Skills

Quality systems

FDA regulations

ISO 13485

Optical measurement equipment

Blueprint reading

Data analysis

Documentation/Reporting

Team collaboration

Education

Associates degree or 2-year technical program

Tools

Gage R&R

Calibration

Test methods

Job 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 DESCRIPTION:

Job Title

Quality Inspector II

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’ll also have access to:

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

The Opportunity

This position will work out of our Minnetonka, MN location in our Vascular Division. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.THIS IS AN ONSITE DAILY REQUIRED POSITION.

As the Quality Technician II, you will be responsible for assisting engineers in developing and maintaining quality engineering methodologies and providing quality technical support within new product development, manufacturing, or system/services support.

What You’ll Work On

• Perform first article incoming inspection of purchased components and inspection of production operations, including documenting inspection and audit results. Perform final product inspections against specification and procedural requirements.
• Document nonconformances as appropriate.
• Monitor and/or perform calibration and maintenance of all test equipment and fixtures.
• Initiate related documentation changes.
• Perform Process Control & Monitoring of critical-to-quality parameters and specifications.
• Collect data, summarize, and document test results.
• Assist with or perform Gage R&R studies.
• Assist with the selection, installation and programming of precision measuring equipment.
• Create and maintain control plans for products and processes.
• Assist in writing, executing and documenting equipment, product, process, and test method verifications, qualifications, and validations.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• 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.

Required Qualifications

• Associatesdegree,completionofa2-yrtechnicalprogramorequivalentexperienceanddemonstrated competence.
• 2-4 years' experience.
• Previous experience in assisting with validations & qualifications, Gage R&R, calibration, test methods, and NCMR dispositioning.
• Knowledge of Quality Systems, FDA regulations, ISO 13485 and applicable worldwide regulatory requirements.
• Experience with optical measurement equipment, hand tools, gages, pressure and force gage testing, and fixture design.
• Training in blueprint reading and experience with sampling techniques.
• Good communication and computer skills, including data analysis and report writing skills.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• 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.

Preferred Qualifications

• Prior medical device experience
• ASQ CQT certification or equivalent
• Experience working in a broader enterprise/cross-division business unit model

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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

$21.05 – $42.15/hour

In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Operations Quality

DIVISION

CRM Cardiac Rhythm Management

LOCATION

United States > Minnesota > Minnetonka : 14900 Minnetonka Industrial Road

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), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf