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Sr Quality Auditor

Current Employee? Job ID 17000SRB

PURPOSE AND SCOPE:

Maintain an effective internal audit program. Coordinate, schedule, and perform internal audits to meet QSR regulations and ISO-9001 requirements. Monitor quality levels throughout all operational areas to achieve compliance with corporate goals and objectives. 

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • A seasoned, experienced professional with a full understanding of internal auditing; resolves a wide range of issues in creative ways.
  • Plan and conduct in-depth audits to fulfill the requirements of the QSR regulations, ISO-9001 requirements and in accordance with Company procedures.
  • Review procedures and quality instructions developed to validate content and to ensure compliance and requirements.
  • Write and revise if needed operating procedures and quality instructions to suit defined requirements and ensure that documentation on file is current and accurately reflects actual operating procedures.
  • Act as a resource to ensure regulatory compliance of manufacturing facility Manufacturing Class II and II medical devices.
  • Train site employees on new Quality regulations/standards. Member of corporate Quality Council
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.  
  • May provide assistance to junior level staff with more complex tasks that require a higher level of understanding of functions.
  • May escalate issues to supervisor/manager for resolution, as deemed necessary.
  • Mentor other staff as applicable.
  • Assist with various projects as assigned by a direct supervisor.
  • Other duties as assigned.
  • Additional responsibilities may include focus on one or more departments or locations.  See applicable addendum for department or location specific functions.



PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION:

Bachelor’s Degree required; Advanced Degree desirable

EXPERIENCE AND REQUIRED SKILLS:

  • 5 – 8 years’ related experience; or a Master’s degree with 3 years’ experience; or a PhD without experience; or equivalent directly related work experience.
  • Basic understanding of a manufacturing environment, related quality concepts,  
  • Basic knowledge of the devices being manufactured
  • Excellent computer skills. Experience with MS Office applications.
  • Ability to communicate, interact and work effectively with staff across all levels of the organization.

EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity

Current Employee?