Quality Manager

 •  IDEX Health & Science Oak Harbor, WA

5 - 7 years experience  •  Healthcare IT

Salary depends on experience
Posted on 07/26/17
5 - 7 years experience
Healthcare IT
Salary depends on experience
Posted on 07/26/17

ESSENTIAL JOB FUNCTIONS

The Manager will work independently and must drive initiatives through earning credibility throughout each function of the organization. S/he will manage projects through indirect or "sphere-of-influence" forms of management. 

  • The QM is responsible for overseeing the Quality Management System, Inspection, Regulatory Compliance, Customer Returns, Supplier Quality and Document Control departments.
  • This position has the overall authority and responsibility as IDEX Health & Science Oak Harbor ISO Management Representative. These responsibilities include:
  • Responsible to create and implement organizational policies, standards and procedures to comply with applicable regulations
  • Responsible for developing and maintaining relationships, as necessary with notified bodies, registrars and customers quality representatives.
  • Manages non-conforming material’s review board (MRB) system including WIP rejects and incoming materials.  
  • Support operations management in assessing material and process defects in support of corrective action programs.
  • In conjunction with the Materials function, actively and continuously pursue improvements in supplier quality, OTD, auditing, and supplier corrective actions.
  • Interface with multiple departments, levels of management, customers and suppliers.
  • Complete and disseminate metric reports.
  • Maintain ISO certification, perform audits and work with auditors to improve processes.
  • Will travel up to 25% to customer and supplier sites.
  • Lead special projects as assigned.
  • Support the Management of Daily Improvement (MDI).
  • Responsible for the overall management of the Quality Department, including staff supervision.




Qualifications:

QUALIFICATIONS

  • Bachelor’s degree in Engineering or other technical discipline preferred.
  • Experience working in an Injection Molding environment is a plus
  • 7 years of progressive experience in Quality Assurance and a minimum of five years management/supervisory experience in a Quality function role.
  • Comprehensive knowledge of quality assurance practices and processes.
  • Excellent knowledge of REACH, RoHs, CE Certification, European Manufacturing Directives, ISO 9001 and 13485, UL544/CSA22.2
  • Internal auditor and continuous improvement experiencerequired.
  • Excellent written/verbal/teaching skills with attention-to-detail.
  • Demonstrated PC, Microsoft Word, Excel and Access database skills.
  • Must have a working knowledge of quality programs, with experience in a variety of measuring/inspection instruments, auditing processes and closed loop corrective action programs.

 

Desirable Traits

  • Self-starter with ability to work independently.
  • Ability to work in both a team environment and autonomously.
  • Excellent listening skills and attention to detail.
  • Multi-task oriented with ability to manage multiple projects and ensure goals and timelines are met.
  • Maintain composure and professional approach when dealing with public.
  • Ability to make decisions logically.
  • Capable of focusing on details with regard to procedures and workflow.

 

IDEX Corporation is a leading manufacturer of diversified products in industries ranging across health, science, safety, fire and fluidics. Operating in 24 countries, IDEX is an innovative and rapidly growing company, focused on delivering excellence through diverse, winning teams. With a strong reputation for providing career growth opportunities, IDEX is a lean, non-bureaucratic and high performing environment.

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