Senior Quality Engineer at Boston Scientific Corporation Malaysia

Carlsbad, California, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

164500.0

Posted On

02 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Component Schematics, Inspection Requirements, Product Quality Improvement, Design History Files, Device Master Records, Device History Records, Calibration Programs, Supplier Quality Activities, Catheter Design, GMPs, Regulatory Standards, Risk Management, Test Method Validation, Statistical Techniques, Minitab, EO Sterilization Validation

Industry

Medical Equipment Manufacturing

Description

Your responsibilities will include: ● Provide technical expertise on component schematics and inspection requirements. ● Identify opportunities for improvement in both product quality and the quality system. ● Ensure accurate development and verification of Design History Files (DHFs), Device Master Records (DMRs), and Device History Records (DHRs). ● Oversee calibration and preventive maintenance programs to ensure equipment reliability (as needed). ● Manage supplier quality activities including audits, performance assessments, and quality agreements (as needed). * ● Bachelor's degree in a scientific or engineering discipline, or an equivalent combination of education and experience. ● Minimum of 5 years' experience in a regulated industry such as medical devices or pharmaceuticals. ● Experience in catheter design and manufacturing while working in Quality. ● Strong understanding of GMPs and regulatory standards (ISO 13485, ISO 14971, FDA 21 CFR Part 820). ● Proficient in interpreting engineering drawings. ● Experience with risk management records and performing risk analysis. ● Hands-on experience with test method validation and Gage R&R studies. ● Knowledge of statistical techniques including normality analysis and tolerance analysis. ● Proficient in Minitab or equivalent statistical software. ● Expertise in EO sterilization validation (ISO 11135). ● Knowledge of biocompatibility standards (ISO 10993 series). ● Self-motivated and capable of working independently in a fast-paced environment. ● Proficiency with MS Office tools: Word, Excel, PowerPoint, Project, and Visio. Requisition ID: 618961 Minimum Salary: $ 86600 Maximum Salary: $ 164500 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 Senior Quality Engineer will provide technical expertise on component schematics and inspection requirements while identifying opportunities for improvement in product quality and the quality system. They will also ensure accurate development and verification of Design History Files, Device Master Records, and Device History Records.