Senior Specialist, Document Control

Work Flexibility: Hybrid

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 be responsible for supporting site periodic reviews, CIDTs, and post release tasks to ensure completion in accordance with the applicable regulatory requirements and standards. 

Essential Duties & Responsibilities: (Detailed Description) 

• 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.  
• Provides timely retrieval of documents and information, as needed 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 participates 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 KPI’s 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 
• Has the ability to work independently 
• Can 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). 

Travel Percentage: 0%