Sr. Quality Systems Manager

Published: October 11, 2018
Location
South Region, Puerto Rico
Job Type
Category
Job Code
22947
Years of Experience
10
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

Description

  • Manages Quality Assurance or Quality Operation organization, to ensure compliance with all elements of a quality management system throughout the organization.
  • Ensures the requirements of the quality systems and business processes are established and maintained in accordance with company policies and regulatory requirements.
  • Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
  • Provides leadership and support for the development and implementation of continuous improvement activities throughout the organization.
  • Establishes and ensures that inspections are conducted prior to the processing of raw materials, ingredients, and product and package specifications, frequently at vendor/supplier locations.
  • Implements policies/procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.
  • Investigates and resolves compliance problems, within the area of responsibility.  Manages recalls and field actions.
  • Reports complaints and ensures that manufacturing related complaints are resolved.
  • Ensures Quality Systems performance is measured and routinely reported to executive management.
  • May be appointed by Executive Management as the Management Representative.
  • Develops, establishes and maintains quality systems programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.
  • Ensures the promotion of awareness of regulatory and customer requirements throughout the organization.
  • Works directly with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
  • Works with Research and Development during new product start‑ups, and establishes key checkpoints for new productions and processes.
  • Investigates and resolves compliance problems, within the areas of responsibility.
  • Performs other positions duties as assigned.

Requirements

  • Bachelor’s Degree in Engineering or equivalent specialization.
  • 10+ years of experience with BS; 7+ years of experience with Masters; 5+ years of experience of leadership role.
  • Medical Devices background is a must.
  • Six Sigma Certified.
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