Boston Scientific Engineer II DQA 

India, Maharashtra, Pune 

118579131

India-Maharashtra, Pune

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