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QA Documentation Associate Job

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Date: Mar 2, 2019

Location: Quincy, MA, US, 02171

Company: Boston Scientific

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

About the role:

The Documentation Associate is responsible for the maintenance and improvement of Boston Scientific Quincy Customer Fulfillment Center documentation and records management quality systems in compliance with company and regulatory policies.  Serves as a quality representative contact on own area of expertise and supports all other change activity.

 

Key responsibilities include:

•             Coordinates the review and revision of documentation submitted on Change Requests according to internal policies and procedures.

•             Coordinates the maintenance and retention of site records in compliance with internal policies and procedures.

•             Prioritize weekly document processing priorities.

•             Prioritize weekly record processing priorities.

•             Copy, distribute and maintain documents in accordance with company procedures. Review final version of documentation changes for any potential issues and work with staff to resolve any issues.

•             Store and maintain all quality records, policies and procedures required for compliance according to internal policies and procedures.

•             Utilize imaging systems to archive documents electronically.

•             Change Notice (CN) Process: Process CN through various stages of the CN process.  This may include CN creation, Submission Review; Implementation, and Document Issuance (Manages the distribution of documents as needed).

•             Assists in gathering change metrics and providing reports as required.

•             Represents the site and participates in Global Community of Practice groups and associated projects as required.

•             Process site nonconformances for Documents and Records sub-process.

•             Interpret and implements Corporate documentation requirements as they relate to local documentation requirements.

•             Provide documentation and change management support as required.

•             Works with designers/engineers to determine model accuracy, design, drafting standards and EDS package documentation.

•             Works with designers/engineers to determine model accuracy, design, drafting standards and EDS package documentation.

•             Perform other duties as required.

 

What we’re looking for:

Minimal qualifications:

•         Associate's degree

•         Document and Record Control experience

•         Proficiency with Microsoft Office suite.

•         Applies continuous improvement principles in development of the quality system.

•         Driven, energetic, self-assured professional with high personal integrity.

•         Ability to develop effective, positive interpersonal relationships  

•         Strong communication and presentation skills.           

 

Preferred qualifications:

•         Bachelor’s degree in Engineering or related field.

•         ASQ or related certifications

•         Windchill experience

•         Experience in nonconforming material and CAPA methodologies/systems       

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 442928

 


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