Overview

Senior Specialist, Document Control at Stryker. The Associate Document Specialist will be primarily responsible for the control, review, release, archiving/storage, and obsolescence of documentation for Stryker site(s), including procedures and specifications. The Associate Document Specialist will also support site periodic reviews, CIDTs, and post-release tasks to ensure completion in accordance with applicable regulatory requirements and standards.

Responsibilities

• Responsible for all activities related to document routing, distribution and release to assure that the latest effective copies are available as required.
• Ensure prompt archiving and storage of applicable Stryker documentation.
• Provide timely retrieval of documents and information to complete investigations, audits and/or reports.
• Provide coaching, guidance and support to functions in use of and navigation of the PLM system and execution of documentation & change processes.
• Identify improvement opportunities within the PLM related processes and participate in improvement initiatives.
• Act as a single point of contact for process owners during the implementation of external Stryker Documents into local QMS, including the CIDT process.
• Report on and input quality KPIs for Stryker site(s) including those related to periodic review, CIDT process, supplier notifications and change activity RFT in support of trending / management reviews.
• Support issue investigations and provide input to correction & resolution, rework, problem solving, and process improvements.
• Assist with company regulatory audit activities, as deemed necessary.

Education & Special Trainings

• High School Diploma or equivalent – United States of America
• Level 5 Certificate or equivalent - Ireland
• EQF Level 4 or equivalent – EU

Qualifications & Experience

• Minimum of 4 years in a Quality/Regulatory Affairs environment with 2 years experience in Document Control or other related function or 0-1 year experience in a Quality/Regulatory Affairs environment with Bachelor’s Degree or equivalent
• Possesses strong communication skills and the ability to manage multiple tasks
• Ability to work independently
• Ability to comprehend verbal and written instructions and prepare written procedures and reports
• Ability to work well in a team environment at multiple levels
• Experience in ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations (Desired)

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Stryker impacts more than 150 million patients annually.