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.
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 response
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 the Site and customers should the need arise.
Is familiar with the internal auditing process.
Qualifications and Skill set:
B.E. in Mechanical/Biomedical/Electrical
6 - 7 Years of experience required
Must have experience in Design Controls (New Product Development)
Must have experience in Risk Management.
Must have experience in Medical Device Regulation – ISO – 13485, 14971.
Must have experience in Usability
Must have experience in Design Verification and Validation.
Must have experience in CAPA and Root Cause Analysis
Must have experience in Test Method Validation
Must have experience in Statistical Tool – Sampling Plan, Variance, Annova/Variance, Minitab.
Excellent Communication required for this role.
Must have experience in Technical Writing
Good to have experience in Process Validation
Good to have experience in Medical Device Quality Management System
Good to have experience in Regulation and standard for Electrical Device
Good to have experience in Sterilization Knowledge
Good to have Six Sigma certification
Good to have experience in Packaging and Labeling
Requisition ID:581345
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!