Boston Scientific
Senior Quality Engineer - 1st Shift
Boston Scientific, Carlsbad, California, United States, 92002
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Senior Quality Engineer - 1st Shift
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Boston Scientific Location: Carlsbad, CA About The Role
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. The 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). Qualifications
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. Compensation
Minimum Salary:
$86,600 Maximum Salary:
$164,500 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see
bscbenefitsconnect.com
– will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. Recruiting Information
Requisition ID: 618960 Boston Scientific is an equal opportunity employer. We are committed to ensuring full implementation of its equal employment policy. All 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. 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. Boston Scientific will comply with all applicable state and federal law and healthcare credentialing requirements. This role is deemed safety‑sensitive and candidates will be subject to a prohibited substance test as a requirement.
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Senior Quality Engineer - 1st Shift
role at
Boston Scientific Location: Carlsbad, CA About The Role
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. The 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). Qualifications
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. Compensation
Minimum Salary:
$86,600 Maximum Salary:
$164,500 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see
bscbenefitsconnect.com
– will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. Recruiting Information
Requisition ID: 618960 Boston Scientific is an equal opportunity employer. We are committed to ensuring full implementation of its equal employment policy. All 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. 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. Boston Scientific will comply with all applicable state and federal law and healthcare credentialing requirements. This role is deemed safety‑sensitive and candidates will be subject to a prohibited substance test as a requirement.
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