Changing lives. Building Careers.
 

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Senior Quality Compliance Specialist - Technical Writer will work with Boston quality system leadership and cross functional owners to create quality system documentation.  This role will also work with process owners and the change control team to develop clear and concise quality system documentation, as part of Integra Boston’s Quality Management System under the direction of the Manager of Document Control and Training or Quality Site Leader.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each primary duty satisfactorily.

Primary responsibilities are to support site change control and document control activities including, but not limited to:

• Provide guidance to multiple cross-functional stakeholders including quality, manufacturing and engineering on communicating technical information.

• Develop, write, edit and revise policies, procedures, forms and technical documentation supporting cross functional teams.

• Collaborate closely with subject matter experts to document processes, create documentation and ensuring applicable standards are met.

• Ensure documents and procedures are up to date, including review of, purpose, content and format.

• Identifying and recommending training materials, procedures and other documents to be developed or updated.

• Review of proposed documentation, highlighting any issues and updating documents accordingly.

• Author documents using Integra templates, style guides, and other guidance documents.

• Author documents per regulatory authority guidelines and requirements.

• Coordinate internal documentation reviews and successfully lead a project team to consensus.

• Write, format, edit, review and proof quality system documentation and regulatory correspondence for technical and non-technical users.

• Other responsibilities as required

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s degree with 5+ year’s of experience or equivalent education and years’ experience in QA/Compliance within the Life Sciences Industry, preferably Medical Device Industry.

• Working knowledge of medical device regulations (including FDA QSRs, ISO13485}

• Experience with one or more of the following key QMS elements: Document Control,

• Record Control, Change Control

• Experience with FDA and/or Notified Body audits/inspections preferred.

• Ability to communicate effectively (both written and oral) using English (or local

• language).

• Demonstrated ability to work cross-functionally in a team environment.

• Must be able to observe company policies and safety procedures at all times.

• Expertise with software and templates commonly used in regulatory medical writing (e.g., MS-Word, Excel, PowerPoint, Adobe Acrobat, EndNote, Reference Manager). Experience with MS-Project preferred.

• Medical device experience is preferred (510(k), PMA, BLA, HCTP).

• Technical writing, presentation, bibliographic research and editorial skills.

• Strong ability to interpret and disseminate relevant product information.

• Strong organizational skills, attention to detail and proofreading skills. Demonstrated project management skills.

• Ability to produce reports and documents independently and evaluate the writing of others.

• Ability to develop expertise in the company's internal document management system

• Works well and efficiently in a fast-paced environment across multiple functional teams.

• Positive, flexible, open-minded attitude; thrives in collaborative environment

• Experience in design control processes is preferred.

• Comfortable educating team members as needed during process of document development

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, print and copy machine as well as other general office equipment.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limit