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Senior Quality Engineer Job

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Date: Oct 1, 2021

Location: Penang, 14, MY

Company: Boston Scientific

Location: Penang, Wilayah Persekutuan Kuala Lumpur (MY-14), Malaysia (MY)
Additional Locations:
Hiring Manager: Jennifer Rowan
Recruiter:
Jason Tan

 

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

  • Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations.
  • Read and interpret technical drawings, procedures, and protocols
  • Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product.
  • 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 responsible for working with process owner to bound product stops and document release criteria.
  • 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.
  • Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
  • Is viewed as a leader in the areas of QSR and ISO/MDD standards within ones own group, constantly promotion awareness of best industry practices making appropriate decisions on a daily basis using the Quality Engineering Manager/Site QA Director as the final arbitrator on critical quality decisions.
  • Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
  • Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
  • Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
  • Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection/approval through to customer awareness/satisfaction.
  • Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
  • Gives technical guidance to Quality Engineers, Associate Quality Engineers, technician and inspection staff.
  • Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
  • Deals with suppliers, other engineering disciplines within and outside of Site and customers should the need arise.
  • Is familiar with the internal auditing process.

 

Requisition ID: 477279

 

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!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


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