Job Description

At Boston Scientific, we draw the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged. If you require accommodation during the recruitment process please do not hesitate to contact a member of the Talent Acquisition team for a confidential discussion.

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we\xe2\x80\x99ll give you the opportunity to harness all that\xe2\x80\x99s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we\xe2\x80\x99ll help you in advancing your skills and career. Here, you\xe2\x80\x99ll be supported in progressing \xe2\x80\x93 whatever your ambitions.

Broad Function

To participate in and support activities in the QA Department ensuring all goods manufactured and services provided by the Company meet the quality requirements of the Company, customers and regulatory authorities.

The primary responsibility of the role is to provide support in the management of Quality System Documentation and Training and provide assistance to sites in these activities as required.

The role is also required to provide quality and compliance support for the core quality system processes for the effective functioning of the Pharmaceutical Quality System.

Principal Responsibilities

Support the effective control of Quality System documentation used by BSC within the pharmaceutical quality system, prioritising work load as required

Operate and support users in the use of the electronic document management system (EDMS)

Issue controlled copies, batch documentation and other quality system documentation

Distribute records and manage the archive and destruction of Quality System documentation

Support the site system administration activities associated with the iQMS

Responsible for communicating document status to sites and departments which the document control function supports

Under direction and leadership of the Quality System Manager, ensure compliance in meeting good documentation practice, good manufacturing practice and data integrity requirements for the management of documentation

Generate documentation and training metrics and provide reports to the Site Leadership Team

Supervise the secure and controlled retention of documents that require off-site archiving

Perform a non-technical review and apply the required formatting as appropriate on all Quality System documentation passing through the Document Control Function

To provide documentation control assistance to all levels as appropriate

Provide support to the site during internal, external and regulatory inspections/audits

Responsible for the issuance of controlled unique reference numbers to support relevant QMS activities e.g. Document Identification Numbers, Technical Protocols and Reports, etc.

Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work accomplished with quality and in accordance with BSC values

Carry out other ad-hoc requests as required by the line manager

The above duties and responsibilities are not an exhaustive list and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.

Principal Relationships

Accountable to \xe2\x80\x93 Quality Assurance Manager

Internal \xe2\x80\x93 Liaise with all departments and Boston Scientific sites as necessary.

External \xe2\x80\x93 Maintain external contacts e.g. suppliers, contract facilities and distributors, where appropriate

Education and Experience required

Educated to A-Level (or equivalent) or equivalent working experience

Experience of working in a regulated industry, ideally a GMP environment

Computer literate including good knowledge of Word, Excel and Visio.

Previous experience in working with an EDMS and Microsoft Teams (SharePoint) will be an advantage

Skills and Attributes required

Demonstrated advanced computer skills \xe2\x80\x93 Microsoft Office, document formatting preferred.

Confident communicator with excellent verbal, written and interpersonal skills.

Able to work under pressure and multi-task with minimal supervision

Competent, highly organised individual who pays strict attention to detail

About us

Purpose and Passion \xe2\x80\x93 Comprehensive Benefits \xe2\x80\x93 Life-Work Integration \xe2\x80\x93 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\xe2\x80\x99re solving some of the most important healthcare industry challenges. Together, we\xe2\x80\x99re one global team committed to making a difference in people lives around the world. This is a place where you can find a career with meaningful purpose \xe2\x80\x93 improving lives through your life\xe2\x80\x99s work.

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\xe2\x80\x99re looking to truly make a difference to people both around the world and around the corner, there\xe2\x80\x99s no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer \xe2\x80\x93 Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Boston Scientific