Senior Quality Engineer

Reposted One Month Ago
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Penang, Daerah Timor Laut, Penang, MYS
In-Office
Expert/Leader
Healthtech
The Role
The Senior Quality Engineer leads problem-solving efforts, ensures compliance with quality standards, and mentors junior team members in the manufacturing sector, particularly in medical devices.
Summary Generated by Built In

Key Responsibilities:

  • Lead structured problem-solving and provide sound engineering and quality recommendations
  • Interpret technical drawings, procedures, and specifications to ensure compliance
  • Make quality-related decisions, including disposition of non-conforming products
  • Investigate manufacturing defects, non-conformances, and customer complaints; identify root causes and implement effective CAPA
  • Support and lead quality investigations, including complaint handling and failure analysis
  • Review and approve validation, operational, and test data to ensure compliance with specifications
  • Drive continuous improvement initiatives across the product lifecycle
  • Provide guidance and technical mentorship to junior team members
  • Collaborate with cross-functional teams, suppliers, and stakeholders to resolve quality issues
  • Support internal audits and ensure compliance with regulatory and quality system requirements

Requirements:

  • Bachelor’s Degree in Science, Engineering, or related field
  • Minimum 9 years of experience in a manufacturing environment, with strong exposure to operations quality
  • Experience in the medical device industry is preferred
  • Experience managing direct reports or in a people management role is an added advantage

Required Skills & Competencies:

  • Good interpersonal, problem-solving, and communication skills
  • Experience in process validation and strong leadership capability
  • Proven ability to resolve issues using structured problem-solving tools, supported by strong knowledge in quality operations, including product risk assessment and data analysis
  • to identify root causes and implement corrective actions
  • Good understanding of ISO 13485 and QMSR (or equivalent regulatory requirements)
  • Experience leading non-conforming event risk assessments and investigations
  • Exposure to project management or involvement in cross-functional projects is an added advantage

About Us

As a global medical technology leader for more than 45 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Skills Required

  • Bachelor's Degree in Science, Engineering, or related field
  • Minimum 9 years of experience in a manufacturing environment
  • Experience in the medical device industry
  • Experience managing direct reports or in a people management role

Boston Scientific Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Boston Scientific and has not been reviewed or approved by Boston Scientific.

  • Healthcare Strength — Healthcare coverage is positioned as comprehensive, spanning medical, dental, vision, life, and disability insurance alongside mental health resources. Family planning support and broader care navigation offerings further strengthen the health-related value of the package.
  • Retirement Support — Retirement benefits stand out through a 401(k) match described as best-in-class and supported by profit sharing and an employee stock purchase plan. High participation in retirement programs is also highlighted as part of the overall financial benefits footprint.
  • Leave & Time Off Breadth — Time off is described as generous, with reports of 20+ vacation days and up to four weeks in some roles, plus paid holidays and sick leave. Longer-term options such as extended unpaid family leave and a personal enrichment sabbatical expand flexibility beyond standard PTO.

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The Company
HQ: Marlborough, MA
52,374 Employees
Year Founded: 1979

What We Do

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 40 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. For more information, visit www.bostonscientific.com and connect with us on X, Instagram, and Facebook. At Boston Scientific, you will find purpose, a place to grow and opportunities to cultivate your passions. To search and apply for open positions, visit https://bostonscientific.eightfold.ai/careers. You may also review our social media guidelines at http://www.bostonscientific.com/social.

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