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

Demonstrates commitment to the Quality Policy (patient safety and product quality) through their daily execution of sound quality practices and the maintenance of an effective quality system. Understands and complies with all the regulations governing the quality systems. Ensures their direct reports are aware of their commitment to patient safety and product quality, are current with their training requirements and that they understand and comply with all other regulations governing their work.

Key Responsibilities

• Identifies and resolves complex exceptions to work assignments.
• Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
• Read and interpret technical drawings, procedures, and protocols
• Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be respons
• Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
• Participates in Customer Complaints investigation for areas under their control.
• Document investigation findings in analysis report on GCS2
• Become a trainer for the Software related with complaints handling process (GCS2), as required.
• Continually seeks to drive improvements in product and process quality.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Evaluates new equipment and processes and participates in the transfer of new products.
• Knowledgeable on QSR and ISO/MDD standards, constantly promoting awareness of best industry practices, making appropriate decision on a daily basis utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality deci
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities
• Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects.
• Knowledgeable on Risk Management , BSEN 14971 requirements.
• Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements.
• Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality.
• Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanliness).
• Gives technical guidance to Associate Quality Engineer, Technician and Inspection staff.
• Is a good team member, fully motivated to achieve and demonstrate best practices in line with the department and Site objectives.
• Deals with suppliers, other engineering disciplines within and outside of the Site and customers should the need arise.
• Is familiar with the internal auditing process.

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

Functional Knowledge

• Requires solid knowledge of conceptual and technical and/or functional knowledge and procedures within own job function and a basic understanding of these elements in related job functions

Business Expertise

• Applies understanding of business drivers and how own team integrates with others to accomplish own work

Leadership

• No supervisory responsibility; may provide informal guidance to new team members

Problem Solving

• Solves problems considering common practice or procedures; determines appropriate action by analyzing possible solutions and their impact on the business or technology using practical experience, judgment and precedents
• Receives a moderate level of guidance and direction

Impact

• Impacts quality and effectiveness of own team and may impact other closely related work teams whose activities are interdependent

Interactions (and Communications)

• Explains factual, sometimes complex and potentially dynamic information to others in straightforward situations.
• Organizes and presents data/ information to influence decision making; primarily to internal audiences

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: 575928

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!

Boston Scientific