Operations Quality Specialist

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 109,000 colleagues serve people in more than 160 countries.

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Irving, TX currently has an opportunity for an Operations Quality Specialist

This newly-created position will be responsible for quality support for manufacturing of FDA medical devices.

70% of all medical decisions are based off diagnostic test results. The medical diagnostic devices we support are those used in hospital and central testing labs to test patients for critical diseases, decide on urgent emergency room conditions, and screen for routine cholesterol, infections, etc. We take pride in knowing we play a key role in the health care of people around the world.

This position is the one that is responsible for the final release for our medical device. If it is not right, we will not ship it. Everyone shares this same goal from Quality to Operations. The person in this role will also help guide and direct manufacturing technicians on the best quality principles to ensure a consistently great product. If failures or rejections occur during manufacturing, we also support the resolution of those non-conformances and final disposition of the parts.

If you want to have direct impact on the manufacturing and release of a critical medical device, then this is a great opportunity for you. It may even be a device that you or a love one may rely on for key medical decisions. We know our own lives may be impacted by tests run on the equipment we manufacture and that makes the job much more meaningful and impactful.

Purpose:

The Operations Quality Specialist will perform a variety and semi-routine tasks to ensure oversight and technical support to daily production activities and support the Quality Operations standards. Under general supervision, ensure compliance to quality system elements and ensure high quality level during manufacturing. Provide technical support in management of non-conformances and manufacturing complaint investigations. Follows standards and procedures in analyzing situations or data from which conclusions can be readily obtained.

Primary Job Scope:
  • Reviews documentation associated with a given product and performs Design History Record (DHR) approvals.
  • Initiates, reviews and approves non-conformances generated for non-conforming material from manufacturing, which includes stock sweeps, rework, scrap and returns.
  • Reviews and approves manufacturing and QC related documents for a given product.
  • Participates in Material Review Board (MRB) meetings.
  • Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to the department manager.
  • Troubleshoots low complexity issues to determine root cause. Participates in investigations related to design, manufacturing or process and applies changes accordingly.
  • Participate on cross-functional teams as operation quality representative.
  • Responsible for implementing and maintaining the effectiveness of the Quality System.
  • Understand and comply with applicable EHS policies, procedures and guidelines.
  • Responsible for independently completing tasks in a timely manner and in accordance with business standards and procedures.
  • Supports investigations by reviewing factory data to determine impact and possible root cause.
  • May provide input to financial and staffing estimates based on program schedule and requirements.


Qualifications:
  • Bachelor'sDegreeorequivalentexperienceanddemonstratedcompetence;additionalpost-graduate educationmaycontributetowardthedesiredyearsofexperience;
  • Typicallyrequires2+yearsofsignificantexperiencetodevelopthecompetencerequiredtomeetthe skillsand responsibilitiesoftheposition;

Candidates/incumbentsshouldpossessthefollowing:

-demonstratedtechnicalcompetencyandworkingtechnicalknowledgeandapplicationofconcepts, practicesandprocedures;

-abilityoraptitudetoworkonproblemsofmoderatescope;

-abilitytoformanddevelopinterpersonal,professionalrelationships;displaysociallyandprofessionally appropriatebehavior;

-abilitytoworkindependentlyandingroups;abilitytoworkcross-functionally;

-abilityoraptitudetoexercisejudgmentwithindefinedproceduresandpracticestodetermine appropriate action;

-demonstratedinitiativeandproblem-solvingskills;critical thinkingskills;

-abilityandaptitudetousevarioustypesofdatabasesandothercomputersoftware;

-abilitytoprioritize;

-strongorganizationalandprojectmanagementskills;

-abilityoraptitudetoprovidesolutionsandcontingencyplansthroughthecomprehensivereviewof alternatives;

-abilitytoquicklygainknowledge,understandingorskillsandiswillingtolearn;

Preferred Qualifications:
  • Above work experience from medical device industry or any other highly-regulated industries, e.g. Defense/Aerospace, Aviation, Automotive, etc.
  • Excellent written and verbal communication skills
  • Able to work under limited supervision.
  • Demonstrated use of Quality tools/methodologies
  • Experience in a highly regulated industry - medical device/aerospace/automotive preferred.
  • Excellent attention to detail.


ABLAUS30993884ENUSEXTERNAL