Joulé · 23 hours ago
Document Control Lead Specialist
Portage, MI
Contract
Onsite
Mid Level
4+ years expJoulé is seeking a Document Control Lead Specialist to manage all activities related to document routing, distribution, and release. The role involves ensuring timely retrieval and archiving of documents, acting as a Subject Matter Expert, and driving improvement initiatives within the Quality Systems team.
Staffing & Recruiting
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
Provides timely retrieval of documents and information, as needed to complete investigations, audits and/or reports
Acts as Subject Matter Expert for document control related activities and processes for the franchise
Develop and provide coaching, training, clinics, support and service to functions in use of and navigation of the PLM system and execution of documentation & change processes
Lead and drive improvement initiatives within the Quality Systems team and participate in multi-functional teams to achieve collaborative results
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, input to & maintain quality KPI’s for Stryker site(s) including periodic review, CIDT process, supplier notifications and Change activity RFT for trending / management reviews
Assist in issue investigations, provide input to correction & resolution, rework, problem solving, and process improvements
Assist with company regulatory audit activities, as deemed necessary
Acts as a backup to the Change Specialist
Qualification
Required
Working towards Bachelor's Degree or higher level education equivalent
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
Ability to gain knowledge and understanding of US and International Medical Device Regulations (ISO 13485, MDSAP, and CFR Part 820 Quality System Regulations desired)
Ability to gain knowledge of supporting Quality Systems (e.g. Audits, Management review, Quality Planning)
Ability to demonstrate basic communication, identify problems, recognizes areas for improvement and contribute to data management and training
Ability to follow instructions, complete task with supervision, identify urgent task and address immediate conflicts
Understands basic regulatory concepts, recognizes industry standards and can identifies key regulations
Understands basic communication principles, understands the importance of their input and participates in group discussions
Participates in virtual team meetings and eagerness to understand roles within a team
Provides updates to supervisors, Shares information with team members, Collaborates with peers
Understands data concepts and identifies basic actions from data
High level of PC skills required
Preferred
Bachelor's Degree – United States of America & Ireland
EQF Level 6 or equivalent– EU
Benefits
Health and welfare benefits coverage options
Medical
Dental
Vision
Spending accounts
Life insurance
Voluntary plans
Participation in a 401(k) plan
Company
Joulé
At Joulé, we believe our world is filled with possibilities – where character, integrity, and commitment drive our purpose.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase