Senior Quality Engineer - 1st Shift

Boston Scientific•Carlsbad, CA

33d•$86,600 - $164,500•Onsite

About The Position

Boston Scientific is seeking a First Shift Senior Quality Engineer to provide quality engineering leadership and support for manufacturing process development and implementation. This position partners closely with Manufacturing to ensure the production of disposable medical catheters complies with all applicable regulatory and quality system requirements. This role plays a critical function in driving validation activities, risk management, and product lifecycle support while ensuring a robust and compliant manufacturing process.

Requirements

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.

Nice To Haves

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.

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).