Manager, Quality Systems (Hybrid)

Job Title
Manager, Quality Systems - Document Control

FLSA Status
Exempt

Position Summary
The Manager, Quality Systems - Document Control reports directly to Senior Manager, Document Control and Training. This position will manage and coordinate functional activities of document and record control, including periodic review, retention, storage, and change control. The position maintains and ensures manufacturing and QA conformance to internal specifications and to GMP regulatory requirements. The position supports improved customer service, both internally and externally by maintaining strong relationships with business partners.

Essential Duties & Responsibilities
   Manage and coordinate site-wide change control activities to ensure that QMS documents and records meet quality requirements.
   Direct employees based on company policies and coordinate team activities and responsibilities.
   Analyze, evaluate, and plan methods for the solution of complex problems.
   Establish department metrics for key aspects of function performance.
   Support timely and adequate integration of harmonized processes to global and local Quality Systems.
   Create and process change packages which include performing document searches and creating redline documents.   Resolve problems/discrepancies on issues pertaining to incorrect or unclear change forms or redlines.
   Develop department policies and procedures with a high degree of accuracy and in compliance with approved formats, templates, and procedures.
   Manage the review, revision, routing, and approval of document packages in the document control system.
   Assure accurate and orderly file maintenance of current and historical documents.
   Establish individual and team performance goals and meet corporate quality objectives.
   Work on special projects as they arise.

Knowledge, Skills & Qualifications
   Ability to complete complex projects with peer input and guidance from management.
   Ability to supervise and manage projects and subordinates.
   Expert in field of expertise and familiar in other areas of expertise within the team..
   Familiarity with cGMP, FDA, and guidelines governing medical devices.
   Strong verbal and written communication skills .
   Excellent organizational skills.
   Able to work independently and delegate task to others in a fast-paced environment.
   Able to multitask while working on long term projects.

Education and Experience 
   Must be at least 18 years of age.
   Bachelor's Degree from an accredited college or university (business, teaching, science/biology)
   Minimum 8 years of experience required, preferably in a regulatory, quality or compliance position of quality assurance experience in a related field.
   2 - 4 years of management experience.

Physical Requirements and Work Environment
   This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets.
   While performing the duties of this job, the employee may be required to sit or stand for long periods of time.
   Must be able to occasionally move and lift objects of up to 25 pounds.
   Typically requires travel less than 5% of the time.

ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.