the smart solution for Grand Rapids jobs

Quality Manager

Company: Skytron, LLC
Location: Grand Rapids
Posted on: November 9, 2018

Job Description:

SummaryThe Quality Manager will communicate to provide, guidance and direction to all individuals within the company, outside vendors, contractors within the organization delivering counsel on business opportunities and developments impacted by regulatory requirements and to ensure that the company maintains a state of readiness for inspection by regulatory agencies. The individual will serve as a confidential point of contact for employees to communicate with management, seek clarification on issues or dilemmas, or report irregularities. Maintain documentation of compliance activities including complaints received and investigation outcomes. Responsible for maintenance and improvement of Quality Management System ensuring compliance to Health Canada, ISO13485, MDD, and FDA cGMP regulatory compliance. Create and execute quality and regulatory policies. Manage activities through subordinates to conduct and maintain internal and external audits, report violations of compliance or regulatory standards to duly authorized enforcement agencies as appropriate or required, execute and manage field corrections, and supervise the filing.Job Qualifications


  • Develop, implement, manage, audit and plan quality systems to support commercial and development activities with sales in multiple countries ensuring compliance with regulatory standards.

  • Develop strategies and tactics to lead the Skytron organization to operate its business within the regulatory requirements ofISO13485, GMP, FDA and other regulatory bodies that impact Skytron's ability to offer products and services to our customers.

  • Lead, direct, coach and support an organization that recognizes, understands, and executes the company's quality and regulatory system. This includes directing continuous improvement initiatives across the organization to improve our products and systems to deliver products and services that meet the regulatory requirements and the performance of requirements of our customers.

  • Conduct or direct the internal investigation of compliance issues. Direct the execution of effective programs for CAPAs, field corrections, recalls, SCARs and audit processes to ensure that nonconforming products are adequately isolated and contained from customer use.

  • Employing independent market surveillance direct the QA organization to monitor performance and feedback from customers.

  • Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.

  • Achieves financial objectives by preparing the quality assurance budget; scheduling expenditures; analyzing variances; initiating corrective actions. Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.

  • Represent QA at senior management, project, Board, and review meetings.

    Education, Training, and Licensure/Certification

    • A BS/BA degree is required; a MBA or I is desired in relevant discipline.

    • Previous experience equal to 5+ years leading a quality organization in a highly regulated field is required. Direct experience with FDA and other health authorities. Experience leading the quality organization of a medical capital equipment manufacturer is highly desired. Knowledge of US cGMP compliance regulations and industry best practices, as well as EU MDD and ISO 13485 requirements.

      Knowledge, Skills, and Abilities

      • Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology. English Language - Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. Customer and Personal Service - Knowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction. See more occupations related to this knowledge.

      • Strong candidate will possess extensive knowledge of the regulatory environment of ISO 13485, UDI, FDA cGMP, Health Canada Inspectorate. Knowledge of navigating the 510K process and listing classified product (Class 1 & Class 2) is also desired as well as knowledge of World Customs Organization's Harmonized System (HS).

        To ApplyPlease submit your resume along with a cover letter that highlights your experience against the job qualification and includes your salary requirements to

        If you need assistance with any aspect of the application process, please contact Skytron's Human Resources Department at or (800) 759-8766.

        Keywords: Skytron, LLC, Grand Rapids , Quality Manager, Executive , Grand Rapids, Michigan

        Click here to apply!

        Didn't find what you're looking for? Search again!

        I'm looking for
        in category

Other Executive Jobs

College Graduates - Executive Team Leader (Assistant Manager) - Pennsylvania/Delaware/Baltimore
Description: One of the world's leading and most recognized brands comes to life in our stores, where guests are still captivated by everything that made them fall in love with Target. Our approximately 1800 locations (more...)
Company: Target
Location: Lansing
Posted on: 11/20/2018

College Graduates - Executive Team Leader (Assistant Manager) - Lehigh Valley, Pennsylvania
Description: One of the world's leading and most recognized brands comes to life in our stores, where guests are still captivated by everything that made them fall in love with Target. Our approximately 1800 locations (more...)
Company: Target
Location: South Bend
Posted on: 11/20/2018

Assistant Manager Convenience Store
Description: The Company markets and distributes petroleum and propane products to over 150 independent service station operatorswith gasoline, diesel, and motor oil products and operates 130 convenience stores.Full (more...)
Company: Cameron Craig Group
Location: Lansing
Posted on: 11/20/2018

Director of Accounting and Administration (Controller) - Labeltape Inc
Description: Job DescriptionDo you have experience in a small- to mid-sized manufacturing environment Do you bring strong GAAP knowledge and Manufacturing ERP accounting experience If yes, read on This Grand Rapids-based (more...)
Company: Amy Cell LLC
Location: Grand Rapids
Posted on: 11/20/2018

Description: Company Overview Dollar General NYSE: DG is a Fortune 200 company with more than 15,000 retail locations in 44 states, 15 distribution centers and 130,000 employees that embody our mission of Serving (more...)
Company: Dollar General
Location: Midland
Posted on: 11/20/2018

VP of Finance
Description: SCOPE OF POSITION: Responsible for the successful overall direction, administration and coordination of all activities of the Accounting, Cage, Count Team, Financial Analysis, and Income Audit departments, (more...)
Company: Hotels / Resorts / Casinos / Hospitality, Battle C
Location: Battle Creek
Posted on: 11/20/2018

Medical Case Manager II
Description: JOB SUMMARY:The Medical Case Manager coordinates resources and creates flexible, cost-effective options for ill or injured individuals on a case-by-case basis to facilitate quality individualized treatment (more...)
Company: Corvel Corporation
Location: Grand Rapids
Posted on: 11/18/2018

Quality Manager Ionia 2109969
Description: Our company has an immediate opening for a Quality Manager. We are looking for an aggressive self-starter who has demonstrated success in spearheading continuous improvement efforts in automotive quality (more...)
Company: NetHire
Location: Grand Rapids
Posted on: 11/20/2018

Medical Director - Hospice (Per Diem, Contract) (IN, Elkhart)
Description: JOB ADVERTISEMENTAs a Medical Director or Hospice Physician with AseraCare Hospice, you have the opportunity to work with our
Company: Aseracare
Location: Elkhart
Posted on: 11/20/2018

Environmental Project Manager with Security Clearance
Description: United States of America - Michigan, Grand Rapids Job Summary Fully qualified scientist. Utilizes scientific principles, theories, practices and existing technologies to develop technical solutions (more...)
Company: AECOM Corp - Worldwide HQ
Location: Grand Rapids
Posted on: 11/20/2018

Log In or Create An Account

Get the latest Michigan jobs by following @recnetMI on Twitter!

Grand Rapids RSS job feeds