CoorsTek Medical
  • 04-Dec-2018 to 02-Feb-2019 (MST)
  • Dayton Manufacturing
  • Vandalia, OH, USA
  • 65,000+
  • Salary
  • Full Time

Medical, Dental, Vision, 6% match 401K, PTO, Holiday Pay, Life Ins, Pet Ins, Short/Long Term Disability, Legal


PRIMARY FUNCTIONS 

The primary functions of the Document Control Supervisor will include establishing a procedural framework for maintaining the controlled documents for the Quality Management System (QMS).  This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools.

 

Ensure Associates are provided with adequate training and support to enable them to successfully do their job.

 

Provide an interface to IT Support for Document Control issues, which include process improvements to existing software, developing recommendations for new hardware and/or software that may benefit the company. Responsible for supervising document control personnel, document control services, and ensuring the quality management system is followed.

 

QUALIFICATIONS: 

To perform this job successfully, an individual must be able to perform each of the Major Responsibilities, including the following: 

  • Maintains the documentation files in compliance with ISO 13485, 21 CFR Part 820 and 21 CFR Part 11.
  • Capable of creating, revising, approving and issuing effective work instructions, procedures and forms which meet regulatory standards as well as ease of use on the production floor.
  • Supervise others to ensure proper revision changes, releases, and document standards are met.
  • Oversees and is responsible to maintain the integrity of the document control and training system. 
  • Responsible for the formal quality systems records including DMR and DHF.
  • Creates, maintains and improves controls on all documentation masters, device history records and files.
  • Support internal / external audits by providing hardcopy and/or electronic records.
  • Familiar with electronic Quality Management System (eQMS) requirements including change control, training, document control and records management.
  • Supervises compliance, timeliness, and accuracy of routing and supporting documentation to customer specification.  Authorized to correct as necessary. 
  • Responsible for receiving and final inspection for labels and packaging.  Maintains the label control sheets. 
  • Authorized to deny access and to include, replace, revise or make obsolete documents there in. 
  • Responsibility to confirm the accuracy of Work Instructions or other documents against specifications, whenever possible. 
  • Maintains and updates Standards Library and database, orders standards as needed.
  • Must be a self-starter attitude with proactive, results-oriented focus; and willing and capable to assume additional responsibilities.
  •  

SUPERVISORY RESPONSIBILITIES

  • Provides supervison to insure all functions are successfully completed.
  • Provides growth plan and employee development.
  • Effectively evaluates Document Control department's performance and provides coaching and mentoring to set performance standards, assess performance capability, and prescribe remediation (including coaching, learning assignments, and training opportunities).
  • Capable of interviewing, hiring, disciplining and terminating according to the implemented policies in a fair and defensible professional manner.
  • Motivates their team to define and meet performance expectations and, while collaborating effectively across functionally boundaries.
  • Other duties as assigned.

 

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

EDUCATION and/or EXPERIENCE: 

  • A four-year degree is preferred, however a two-year degree with courses and/or seminars in engineering, change control, change requests, project management, is acceptable.
  • Ten years of document control experience, with at least five-years in medical device industry or contract manufacturing.
  • Experience with Microsoft Office Suite of software is required. 
  • Experience with Adobe Acrobat is required.
  • Experience with eQMS software is preferred, QAD/CEBOS is highly desireable.
  • Demonstrated experience with routine Document Control hardware and software, such as scanners, optical character recognition.

 

LANGUAGE SKILLS: 

  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals.
  • Ability to write routine reports and correspondence.
  • Ability to speak effectively before groups of customers or employees of organization.

 

MATHEMATICAL SKILLS 

  • Ability to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.
  • Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

 

REASONING ABILITY: 

  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

 

PHYSICAL DEMANDS: 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

While performing the duties of this job, the employee is frequently required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and stoop, kneel, crouch, or crawl.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities required by this job include close vision.

 

WORK ENVIRONMENT: 

The 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.

CoorsTek Medical
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