Document Control Specialist in Salt Lake City, UT at Stryker Corporation

Date Posted: 10/9/2018

Job Snapshot

Job Description

Qualifications/Work Experience Required

  •  5+ years experience in Documentation control, preferably in the medical device Industry.
  • Thorough knowledge of GMP and Quality Systems required.
  • Strong organization and project management skills
  • Ability to work well in a team environment at multiple levels
  • Ability to influence others
  • Strong interpersonal relationship skills
  • Excellent computer skills.

Job Summary

(1-2 sentences describing overall responsibilities)

  • This position is primarily responsible for the Document Services activities within the company including, change control, issuance and obsolescence and training aspects related to the applicable Documentation control regulatory requirements.

Essential Duties & Responsibilities

(detailed description)

  • Maintain accurate "change control" within the defined quality system, and archiving of obsolete materials.
  • Support the structural integrity of the implemented Quality System.
  • Maintenance and storage of documents & data.
  • Control of DMR's, LHR's, revisions, and tracking of change orders.
  • Effective interface & communication with functional disciplines to ensure efficient and constructive interdepartmental interactions for Documentation and change control aspects.
  • Provide training to cross functional groups on PLM and regulatory requirements related to Documentation control.
  • Periodic/requested participation in product development team settings for coordination of necessary documentation activities.
  • Support & comply with GMP/QSR, ISO 13485 & CE-mark requirements.
  • Coordinate the dissemination of controlled documents.
  • Develop & maintain quality indices for trending/management reviews.
  • Schedule & supervise Document Control maintenance activities, as necessary.
  • Maintain an organized, clean, safe & health conscious work environment.
  • Assist with company regulatory audit activities, as deemed necessary.

Work From Home: No

Travel Percentage: None

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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