Senior Quality Engineer - 1st Shift

Senior Quality Engineer - 1st Shift

Boston Scientific Corporation Malaysia

Location:

Carlsbad, California, United States

Employment Type:

Full Time

Start Date:

Immediate

Expiry Date: 02 Mar, 26

Posted On: 02 Dec, 25

Remote Job:
Yes

Telecommute:
Yes

Sponsor Visa:
No

Experience

Required:

5 year(s) or above

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, Medical Equipment Manufacturing

• 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).
• Work independently in a fast‑paced environment.

• • 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).
• • Proficiency with MS Office tools:
  Word, Excel, PowerPoint, Project, and Visio.

Requisition
Minimum Salary: $86,600
Maximum Salary: $164,500

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.

We stand for inclusion, equality, and opportunity for all. 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 require adequate proof of COVID‑19 vaccination status and may require a prohibited substance test. This role is deemed safety‑sensitive.

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!