Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Client designs, develops, manufactures and markets orthopedics products, including knee, hip, shoulder, elbow, foot and ankle artificial joints and dental prostheses. client has operations in more than 40 countries around the world
Job Title: Document Control Specialist
Work Location:Warsaw, IN 46580
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
Duties:
- Responsible for leading document control and records management processes and for ensuring records are processed retained and updated appropriately.
- Responsible for giving direction to team members within the records management and document control groups and leading projects.
Principal Duties and Responsibilities:
- Serves as the right hand of the department supervisor, helping to process changes and organize daily department priorities, by developing and maintaining trackers and meeting with individual team members
- Answers questions and gives guidance to records management and document control coordinators
- Trains peers on various processes
- Authors and develops new documents and processes
- Manages change control processes and meetings with TMs to ensure timely processing of change requests.
- Identifies and initiates projects to improve department processes with little to no oversight
Skills:
- Action oriented, drives for and achieves results.
- Must be proficient in MS Office and Sharepoint.
- Strong bias for coaching and mentoring others. This includes ability to effectively train team members within a class-room or workshop setting.
- Proven strong writing and editing skills.
- Proven excellent attention to detail and proofreading skills.
- Strong organizational skills and the ability to multi-task.
- Strong and effective communicator (written and verbal).
- Motivated and proven ability to work in a team-oriented, global environment, including interacting effectively with all levels and outside contacts.
- Excellent problem identification and solving skills.
- Sound decision making skills, solid under pressure.
- Effective process development and process management skills.
Education:
- BS/BA in engineering, business, life sciences or a similar discipline required.
- Minimum of 3 - 5 years of experience in a Quality Control, Quality Assurance or Compliance roles, preferably in a document control or function in the medical device or life sciences industry.
- Working Knowledge of 21CFR Parts 11 and 820, including ISO 13485 QMS.
- Experience with electronic Document Management (eDM) systems is preferred.
- Prior experience of participating in compliance audits or inspections is preferred
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Warsaw, IN |
| Industry | Computer/IT Services |
| Salary | $25 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Biologyunmatched
- Change Controlunmatched
- Change Managementunmatched
- Change Requests/Ordersunmatched
- Coachingunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Detail Orientedunmatched
- Diversityunmatched
- Document Controlunmatched
- Document Managementunmatched
- Editingunmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Maintain Complianceunmatched
- Medical Equipmentunmatched
- Mentoringunmatched
- Microsoft Officeunmatched
- Microsoft SharePointunmatched
- Multitaskingunmatched
- Organizational Skillsunmatched
- Orthopedicsunmatched
- Problem Solving Skillsunmatched
- Process Developmentunmatched
- Process Improvementunmatched
- Process Managementunmatched
- Proofreadingunmatched
- Quality Assuranceunmatched
- Quality Controlunmatched
- Records Managementunmatched
- Regulatory Complianceunmatched
- Team Playerunmatched
- Time Managementunmatched
- Training/Teachingunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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