Quality Engineer, CAPA at Boston Scientific Corporation Malaysia

Carlsbad, California, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Feb, 26

Salary

115900.0

Posted On

21 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Engineering, CAPA Processes, Root Cause Investigations, Regulatory Requirements, FDA QSR, ISO 13485, ISO 14971, EU MDR, Six Sigma, Lean, Kaizen, eQMS, TrackWise, Communication Skills, Documentation Skills, Project Management

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: * ● Bachelor's degree in Engineering, Life Sciences, or a related field. ● Minimum of 5 years' experience in Quality Engineering, preferably in a regulated industry (e.g., medical devices or pharmaceuticals). ● Proven experience managing CAPA processes and leading root cause investigations. ● Strong understanding of regulatory requirements including FDA QSR, ISO 13485, ISO 14971, and EU MDR. ● Proficiency with quality tools and methodologies such as Six Sigma, Lean, and Kaizen. ● Experience with electronic Quality Management Systems (eQMS), such as TrackWise or similar platforms. ● Excellent communication, documentation, and project management skills. ● Certified Quality Engineer (CQE), Six Sigma Green or Black Belt, or similar certification. ● Experience in complaint handling, nonconformance investigations, and post-market surveillance. Requisition ID: 618962 Minimum Salary: $ 61000 Maximum Salary: $ 115900 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. 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. 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! 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. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

Responsibilities

The Quality Engineer will manage CAPA processes and lead root cause investigations. The role requires a strong understanding of regulatory requirements and proficiency with quality tools and methodologies.