Job Description

Additional Locations: India-Maharashtra, Pune

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

At Boston Scientific, we'll give you the opportunity to harness all that's 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'll help you in advancing your skills and career. Here, you'll be supported in progressing - whatever your ambitions.

Purpose Statement

The R&D Quality System engineer will be a part of the R&D Quality organization. The individual will be responsible for sustaining and continually improving the site quality system, facilitating and conducting audits and coordinating the CAPA process. The individual must be self-driven as well as a team player who is willing to collaborate and work with different cross functional teams across geographies and cultures.

Key Responsibilities

• Owns, sustains and continually improves the site quality management system by executing the existing requirements and by driving improvement and simplification initiatives.
• Drives and implements all the globally driven initiatives/changes at the site in the areas of Quality Management System, Audits (Internal and External), Document and Record Control and CAPA.
• Collaborates with the extended global teams for participation in different global/site projects. Represents the site in different global/regional communities of practice.
• Facilitates the quarterly management reviews and CAPA review board meetings for the site along with the site management representative.
• Facilitates external audits with the notified body. Supports and conducts internal audits for the site.
• Participate in quality planning for the site. Drives awareness sessions in the space of quality management system for the site as identified and Supports the site users for all document control activities.
• Authors and owns all site documents in the space of Quality management system, Audits, Document and Record Control and CAPA. Guides and train users at the site for different quality management system related aspects.
• Maintain records as per the site/organization's record management process.
• Coordinates NCs and CAPAs for the site. Drives the Non-conformance and CAPA metrics and mentor record owners.
• Drives quality culture at the site through various trainings and other employee engagement activities.

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Management Requirements

• Not applicable.

Job Scope and Leveling Guidelines

Knowledge

A developing professional. Working knowledge and application of business and technical concepts, procedures and practices. General knowledge of industry practices, techniques, and standards. General understanding of business unit/group function. Exercises judgment when interpreting company policies and procedures to resolve a variety of issues.

Problem Solving

Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

Planning and Organization

Plans, organizes, and prioritizes own daily work routine to meet established schedule.

Discretion/Latitude; Supervision Received; Decision Making

Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems, interpretating established policies, procedures and practices. Work is reviewed for soundness of judgment.

Business Relationships and Project Management

Cultivates a wide range of internal business relationships and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of small to moderate scope. Influence exerted at peer level and occasionally at first levels of management.

Impact

Contributes to the completion of departmental projects and goals. Errors in judgment, poor recommendations, or failure to achieve results would normally require a moderate expenditure of resources to rectify.

Liaison

Engages with internal company and external contacts. Represents organization on specific projects. Uses diplomacy and tact in interactions and problem solving.

Mentoring

Provides guidance to less experienced staff.

The above statements are intended to describe the general nature and level of work being performed
by people assigned to this classification. They are not intended to be construed as an exhaustive list
of all responsibilities, duties and skills required of personnel so classified. Job-specific training requirements associated with responsibilities and tasks personnel perform are established and demonstrated through their individual learning plan.

Please contact your local EH&S department for more information on physical requirements.

Requisition ID: 554489

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!