Kelly Services Technical Writer / Document Control Specialist in Pittsburgh, Pennsylvania

Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 12+ month, long term contract opportunity as a Technical Writer / Document Control Specialist – MDR for a top fortune 500 medical device manufacturing company in Pittsburgh, PA.

Title: Technical Writer / Document Control Specialist – MDR

Duration: 12+ months

Location: Pittsburgh, PA

Pay Range: $30-$37/hour DOE

Must be local to Pittsburgh

Must be US citizen

SUMMARY:

Create, edit, and format policies, procedures, forms, templates, work instructions and other documents as needed for the Global Quality Management System, EU MDR 30% Manage multiple document creation projects at a time. Organize and incorporate suggested changes and edits from multiple subject matter experts. Coordinate with the implementation team to maintain deadlines. 10% Assist Legal Manufacturing Sites with doing Gap Assessments, Redlining Local Documents and preparing them for MDR Certification Audits 40% Compile and maintain master records using electronic and/or paper systems. Maintain document control best practices for each document project. 10% Capture document lifecycle and relevant data for each project using an Excel spreadsheet. 5%

Essential Duties and Responsibilities:

  • Assists with the successful Implementation of Global QMS documents impacted by EUMDR to the 7 Legal Manufacturing Sites

  • Directly work with the Legal Manufacturing Sites with Implementing the EUMDR Impacted Global Implementation Projects

  • Assist sites with Gap Assessments, redlining local documents to reflect MDR needs and reviewing local QMSs for MDR Compliance

  • Leads or supports the update and cross functional reviews of Quality System procedures including obtaining, analyzing and incorporating stakeholder feedback, processing ECRs and ECOs, delivering process training and tracking process performance.

  • Supports the collection, analysis and reporting or Management Review inputs and tracks Management review actions to completion.

  • Partners with Global Training to ensure requirements for Global QMS Training are fulfilled.

  • Create, edit, and format policies, procedures, forms, templates, work instructions and other documents as needed for the Global Quality Management System, EU MDR 30%

  • Manage multiple document creation projects at a time. Organize and incorporate suggested changes and edits from multiple subject matter experts. Coordinate with the implementation team to maintain deadlines. 10%

  • Assist Legal Manufacturing Sites with doing Gap Assessments, Redlining Local Documents and preparing them for MDR Certification Audits 40%

  • Compile and maintain master records using electronic and/or paper systems. Maintain document control best practices for each document project. 10%

  • Capture document lifecycle and relevant data for each project using an Excel spreadsheet. 5%

  • Other QMS documentation responsibilities as needed. 5%

Qualifications:

  • 5+ years’ technical writing; 2+ years’ document control

  • MS Office, Excel, Document Control software

  • Travel requirements: 10/25%

Education / Experience:

  • Associates Degree or equivalent work experience.

Important information : This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online or contact luisa.ruthner@kellyservices.com for immediate consideration

Why Kelly?

  • As a Kelly Services employee, you will have access to numerous perks, including:

  • Exposure to a variety of career opportunities as a result of our expansive network of client companies

  • A competitive hourly pay rate with weekly checks

  • Access to newly expanded Medical Plan options

  • Online continuing education via the Kelly Learning Center

  • Several employee discounts

  • And more!

Why Kelly ® ?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in

industry leading organizations. Top companies throughout the world have trusted Kelly as a premier

source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm

with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety

and flexibility of working on short term project engagements, or prefer contract-to-hire or direct

hire placement with our clients, apply with Kelly to explore opportunities that suit your specific

professional interests.

AboutKelly Services ®

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,

Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is

committed to employing a diverse workforce. Equal Employment Opportunity

is The Law.