Boston Scientific Senior Quality Engineer 

United States, California, Carlsbad 

8265459

About the role:

Boston Scientific is seeking aSenior Quality Engineerto 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.

Your responsibilities will include:

● 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.

Technical expertise:

● 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).

Required qualifications:

● 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 qualifications:

● 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.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay 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 forexempt, non-sales rolesmay 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.

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. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. 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.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. 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.