Harmac Medical Products, Inc, based in Buffalo, N.Y. is a leading, award-winning contract manufacturer of single-use medical devices, serving the global marketplace for more than 40 years. With manufacturing locations in the U.S., Ireland and Mexico, this privately held company provides innovative technical solutions and manufacturing services for leading Fortune 500 med-tech companies and high potential start-ups. Harmac's mission is to change the lives of patients, employees and the communities in which we work.Want to work for a growing company that's positively impacting the people in your community? At Harmac, you can do just that.
Position: Quality EngineerReports to: QA ManagerDepartment: QualityReview date: May 2021
Job Summary:
Plans and directs activities concerned with development, application, and maintenance of quality standards for
industrial processes, materials, and products by performing the following job duties.
Job Duties
Follow all Safety and Quality requirements
Live the values of the company: Respect, Integrity and Honesty.
Effectively leads, participates on, and/or monitors cross functional teams related to process/product
improvement, and/or root cause analysis as required.
Develops and initiates standards and methods for inspection, testing, and evaluation.
Devises sampling procedures and designs and develops forms and instructions for recording, evaluating,
and reporting quality and reliability data.
Establishes program to evaluate precision and accuracy of production equipment and testing,
measurement, and analytical equipment and facilities.
Develops and implements methods and procedures for disposition of discrepant material and devises
methods to assess cost and responsibility.
Directs workers engaged in measuring and testing product and tabulating data concerning materials,
product, or process quality and reliability.
May supervise QA personnel when required.
May perform, oversee or coordinate activities associated with software validation.
May conduct external audits and serve in the capacity of Supplier Quality Engineer when necessary
Other duties as assigned.
Other assigned tasks
Ensure cost containment levels are maintained
Analyze potential areas for savings or efficiencies
Experience and education required:
Bachelor's degree in an Engineering discipline.
4+ years related experience in the field or in a related field
ASQ, CQE Certification is a plus.
Communication Skills.
Requires an above average people skills ability.
ISO Certification as an Auditor is a plus
Commitment to the Job Quality Focused Productive
Communications skills Accountable Trustworthy
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