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Quality Systems Engineer


Requisition Number: P10277

Region: US
State: Wisconsin
City: Menomonie

Responsibilities

Objective: Responsible for managing corporate Unified Quality Management System and providing compliance support in specific areas related to Quality and GMP for Medical product sites. 

  • Interfaces with sites and their QA organizations to review policies and procedures, regulations, and work instructions 
  • Participates in audits and regulatory inspections (as needed)
  • Oversees the management of the UQMS Document Control system including writing SOPs, work instructions, etc.
  • Provide GMP guidance to facility personnel
  • Facilitate communication between functions and multi-facility groups
  • Evaluate processes for updating techniques, quality and overall efficiency to improve operations
  • Instill a mindset that will proactively cause those involved in the business to put all GMP regulations at the forefront of their day-to-day activities
  • Regularly research and evaluate regulatory trends to insure the compliant systems
  • Help employees improve upon or enhance existing skills
  • Identify training and compliance gaps and address with appropriate departments
  • Provide periodic status updates and reports
  • Reviews regulatory, program and customer requirements ensuring early quality involvement in program development
  • Maintain internal audit program; track audit findings from internal audit and compliance audit programs; Measure audit program progress, reporting results to management
  • Monitor activities/publications of FDA and international regulatory bodies to identify and respond to new or revised regulatory requirements 
  • Completes customer surveys and creates regulatory statements as required by customers such as BSE/TSE origin, stability and others
  • Assist the Director of Quality with the development, implementation and maintenance of regulatory procedures 
  • Other duties as assigned
  • Some programs may have vision requirements
  • Safety/Environmental:
  • -Where applicable, individual is pre-planning safety into work activities to improve performance
  • -Proactively identifies safety concerns
  • -Complies with Environmental Management System program SOP’s/WI, Policy & Program elements and encourages responsible use of resources
  • -Actively participate in continual improvement/innovation, corrective action and internal/external customer satisfaction

Qualifications - Education & Experience

  • BS plus two years of related experience within a regulated environment, or equivalent industry experience 
  • Knowledge of GMPs Regulations (13485, 820, 210/211, EU)
  • Internal Auditor (external lead training preferred)
  • Ability to manage small projects/programs with limited assistance from others
  • Understanding of computer tools and systems
  • Ability to learn communication, teamwork, and organizational skills
  • Understanding of the key processes and systems of the position
  • Ability to meet timelines

Qualifications - Skills & Competencies

  • Knowledge of FDA Quality System Requirements, ISO 13485, ISO 9001, ISO 14971 and other medical device regulations, both domestic and international.
  • Must interact with all levels of managements, co-workers, and regulators
  • Leadership skills including ability to maintain confidentiality
  • Ability to read and interpret FDA Guidelines, professional journals and technical procedures
  • Decision making and prioritization skills
  • Strong written, verbal and interpersonal communication skills
  • Satisfactory work and attendance record
  • Strong organizational skills
  • Willing to work flexible hours to accommodate business needs                                  

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