Company: Skytron, LLC
Location: Grand Rapids
Posted on: November 9, 2018
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 firstname.lastname@example.org.
If you need assistance with any aspect of the application process, please contact Skytron's Human Resources Department at email@example.com or (800) 759-8766.
Keywords: Skytron, LLC, Grand Rapids , Quality Manager, Executive , Grand Rapids, Michigan
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