Boston Scientific · 1 month ago
Senior Quality Engineer - 1st Shift
Carlsbad, CA
Full-time
Onsite
Mid, Senior Level
$87K/yr - $164K/yr
5+ years expBoston Scientific is a leader in medical science, committed to solving important health industry challenges. They are seeking a Senior Quality Engineer to provide quality engineering leadership and support for manufacturing process development and implementation, ensuring compliance with regulatory and quality system requirements.
Health CareMedicalMedical Device
No H1B
Responsibilities
Oversee ethylene oxide (EO) sterilization validation processes and ensure routine sterilization meets regulatory standards
Support environmental monitoring and cleanroom verifications per schedule; assist with excursion investigations
Review and approve manufacturing validation test plans, protocols, and reports
Lead completion of risk management deliverables, including process Failure Mode and Effects Analyses (pFMEA) and Control Plans
Support and lead test method validation activities to ensure reliable and accurate testing
Develop, review, and approve inspection plans, Device History Records (DHRs), and product drawings for new products
Create and implement quality plans to ensure product and process compliance
Drive defect prevention and detection efforts within manufacturing
Provide statistical support and problem-solving expertise for process validations and engineering protocols
Support Management Review, internal/external audits, deviations, CAPAs, NCRs, supplier management, and RGAs
Provide quality support for New Product Development activities
Lead resolution of quality issues related to CAPAs and NCRs
Ensure compliance with quality system procedures and applicable regulations
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)
Qualification
Required
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
Preferred
Expertise in EO sterilization validation (ISO 11135)
Knowledge of biocompatibility standards (ISO 10993 series)
Strong analytical, planning, and organizational skills
Excellent written and verbal communication skills
Self-motivated and capable of working independently in a fast-paced environment
Proficiency with MS Office tools: Word, Excel, PowerPoint, Project, and Visio
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
BioWorld Financial Watch
2025-12-25
2025-12-12
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