Job title: Quality Documentation Specialist II Job
Company: Boston Scientific
Job description: Additional Locations:
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:
This person will be responsible for the coordination of data for Quality Systems project(s) reviews: review and summarize data into presentation format for site senior quality management assessment.
Supports various aspects of the local research and development team and manufacturing process team. Provides updates to management on delinquent training and provides support to internal audit team.
Your responsibilities include:
- Maintain department training matrix.
- Assist in maintenance of audit files.
- Coordinate PIR/NCEP data forms for weekly review.
- Participate as a member of site audit support team.
- Support internal audit program as a qualified auditor and program coordinator.
- Prepares periodic reports to management on the status of key areas.
- May develop and establish quality assurance policies, processes, procedures and controls ensuring the efficiency and ongoing improvement of the quality system elements.
- Prepares new and revised documents for routing per the local document approval process. Tracks progress in obtaining approvals to for document change notices to aid in timely approvals.
- Incorporates documentation edits and updates all logs associated with documentation status. Releases approved documents and notifies affected personnel of changes impacting functional areas.
- Suggests changes to processes documentation and training programs in the spirit of continuous improvement.
- Supports teams in implementation of quality systems upgrades.
- Monitors and documents compliance with the local training program to ensure training compliance.
- Support quality related needs of various departments including Operations, R&D. This includes validation documentation, manufacturing process instructions and quality planning support.
- Help maintain various spreadsheets and databases for quality systems processes.
What we’re looking for:
- Bachelor’s degree -preferred
- 3+ years of related experience
- Experience working within and maintaining quality documentation system within a regulated environment (ISO 13485 preferred)
- MasterControl experience – preferred
- Advanced user in Excel, Word and all Microsoft platforms
- Technical Writing experience (drafting reports and procedures based on technical information)
- Project management experience an asset
- Highly organized
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.
Requisition ID: 468028
Location: Ottawa, ON
Job date: Sat, 05 Sep 2020 05:17:28 GMT