Physio-Control - Compliance Eng Project Analyst - Redmond, WA in Redmond, WA at Stryker Corporation

Date Posted: 9/19/2018

Job Snapshot

Job Description

GENERAL SUMMARY:

The Compliance Engineering Project Manager supports the Compliance Engineering Manager and Compliance Engineers in planning, coordinating, monitoring and executing Compliance Engineering projects.  Creates and maintains Technical documentation files, Declarations of Conformity, and other standards lists and documents. Independently performs many complex specialized function-related tasks.


MAJOR DUTIES/RESPONSIBILITIES:

  • Creates and manages Technical Documentation Files and Declaration of Conformities.
  • Reviews MDD-TRF checklists.
  • Ability to handle majority of internal and external requests independently and seek consultation when needed.
  • Interacts with Compliance Engineers, peers, and other departments, on matters of significant importance on a frequent basis.  Involves planning and preparation of the communications. Requires skill, tact, persuasion, judgment, and/or negotiation to accomplish objectives.
  • Manages preparation, conduct and responses for external audits such as TUV, TUV Brazil, CSA, Intertek, internal audits and other 3rd party external audits.
  • Creates and Manages Quality Plans as needed for Compliance Engineering.
  • Manages the preparation of TUV and FAA Notifications.
  • Manages the External Standards library to maintain access to current standards and provides periodic reports.
  • Manages Standards Evaluations forms and procedure to ensure all standards are implemented prior to mandatory dates.
  • Manages - OEM / Accessory Declarations of Conformity and Certification. Manages - GMDNS codes for all products and accessories.
  • Create and maintains Compliance Engineering work instructions, process, procedures, templates 17025 training documents and standards in SmartSolve (Pilgrim)
  • May be assigned Project Management Responsibilities for small projects. (example EC Rep project)
  • Applies extensive knowledge of and experience in company operations to assist in the development, implementation and administration of project guidelines and procedures.  Identifies and implements process improvements.
  • Conducts research, gathers and compiles information for reports. Analyzes results and communicates project status.
  • Provides skilled technical support with minimal direction, which may include data coordination, data analysis, tracking and coding.  

BASIC QUALIFICATIONS

  • High School diploma or equivalent
  • 5 years of related experience

PREFERRED/DESIRED QUALIFICATIONS

  • Computer training including use of the internet
  • Intermediate knowledge of Microsoft Office applications (Outlook, Word, Excel, PowerPoint, Access)
  • Records management
  • Proficient task management including prioritization skills
  • Good problem-solving skills • Advanced communication skills (written as well as verbal)
  • Self-motivated, organized, efficient and process oriented 
  • Team player
  • Strong work ethic
  • Works well under pressure in a dynamic environment
  • Tactful, exercises independent judgment and discretion
  • Professional presentation and strong interpersonal communications skills.

WORKING CONDITIONS:

  • Normal office environment
  • Sit for extended periods of time
  • Occasional lifting – up to 30 pounds  

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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