27 days old

Quality Specialist

St. Louis, MO
Hazelwood, MO 63042
  • Job Code
    127654239

Overview

Aesculap, Inc., a B. Braun company, is part of a 180-year-old global organization focused on meeting the needs of an ever-changing healthcare community. Through close collaboration with its customers, Aesculap provides advanced technologies for general surgery, neurosurgery and closure technologies. Aesculap continues a proud heritage of leadership and responsiveness as we strive to deliver products and services that improve the quality of patients lives.



Responsibilities

Position Summary:

Experienced Quality professional with, FDA Quality Systems Regulations (21 CFR Part 820), ISO 13485 and ISO 14971 experience. Responsible for ensuring the adequacy of inspection and testing methods used to release Set World Sets and other medical devices distributed by Aesculap Inc. and Aesculap Implant Systems. Writes and implements standard operating procedures (SOP) which are necessary to ensure Quality compliance and the safety and performance of Aesculap distributed products. Works closely with other departments including but not limited to Operations, Complaint Handling, Marketing, Supply Chain, and Customer Service to resolve quality related issues.

Responsibilities: Essential Duties

  • Inspects, conducts line clearances and audits certain Operations functions.
  • Supports Spine and Ortho PMT activities as requested.
  • Creates Quality specifications and supports their implementation for new product introductions.
  • Manages the St. Louis Facility Equipment Files and calibration activities.
  • Assists in the qualification of new suppliers and analysis of new products from such suppliers (e.g., instrument testing).
  • Identifies, documents, evaluates and initiates Non-conforming Material Reports (NCMRs) to the Quality management, Quality Board, or Operations Management for resolution.
  • Assists with Equipment and other Process Validations (IQ/OQ and PQs).
  • Assist the Complaint Department by providing product technical evaluations as necessary.
  • Performs Load Sheet implementation.
  • Writes and/or assists in writing new SOPs or revising existing SOPs as required. Assists in the implementation/training of those new or revised documents.
  • Issues monthly reports to the QC management as requested.
  • Must comply with applicable ISO and FDA regulations as stated in Quality Manual.
  • Must embody the Companys Vision, Mission and Values.
  • Other duties may be assigned by manager.

Expertise: Knowledge & Skills

  • Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, public groups, and/or boards of directors.
  • Mathematical Skills: Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
  • Reasoning Ability: Ability to define problems, collect date, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.



Qualifications

Expertise: Qualifications-Experience/Training/Education/Etc

Required:

  • BS in a Life Science or Engineering discipline is preferred (
  • ASQ certification preferred. Qualified candidates with equivalent experience will be considered.
  • Requires a knowledge of FDA Quality System Regulation, ISO 13485 and ISO 14971.
  • Requires understanding of dimensioning and geometric tolerancing.
  • Must have experience in the use and application of sampling plans based on ANSI/ASQC Z1.4 or equivalent.
  • Microsoft Office (Word, Excel, Power Point) and SAP.
  • Must have ability to process, analyze and present data.
  • Good oral and written skills required.
  • Language and mathematical skills; reasoning ability:

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 50 pounds.

B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at www.bbraunusa.com.

Through its Sharing Expertise initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.



PI127654239

Categories

Posted: 2020-12-20 Expires: 2021-01-20

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Quality Specialist

St. Louis, MO
Hazelwood, MO 63042

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