Quality Engineer III

Additional Locations:  N/A

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.

About the Role:

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.

Your Responsibilities Include:

· Identifies and resolves complex exceptions to work assignments.

· Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.

· 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.

· Continually seeks to drive improvements in product and process quality.

· Evaluates new equipment and processes and participates in the transfer of new products.

· Get involve in various stages of equipment and processes validations: Run and / or review and / or approve reports I.Q 's, O.Q' s and P.Q 's as well as any other document relating to validation.

· Read and interpret technical drawings, procedures, and protocols

· Assure that all laboratory equipment complies to perform the analysis activities (calibration, safety, cleanness).

· 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/MDR standards, constantly promoting awareness of best industry practices, making appropriate decision daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions.

· 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.

· 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.

What We’re Looking For:

· Bachelor's degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or related Field.

· Expierence in Process Validation and Transfers required

· English required Level: B2:(70-79%).

· Desired knowledge: ASQ certification (CQE, SSGB) desired, Formal studies in process & product validation is desired as well as thorough understanding of inspection techniques and statistical methods, Scientific tools (e.g. Gage R&R, DOE, process capability.

· At least 3 years of experience in similar position.

#CRTA #CTGTA #QACR

Requisition ID: 615603

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!