Gilead Sciences
Senior Quality Engineer I - Combination Product Development
Gilead Sciences, San Francisco, California, United States, 94199
Senior Quality Engineer I - Combination Product Development Join to apply for the
Senior Quality Engineer I - Combination Product Development
role at
Gilead Sciences .
Find out if this opportunity is a good fit by reading all of the information that follows below. At Gilead, we’re creating a healthier world. For more than 35 years, we’ve tackled diseases and developed therapies to improve lives and to ensure access to these therapies globally. We seek motivated people who will contribute to our mission with collaboration and determination. Key Responsibilities
Serve as a lead quality engineer for medical device combination product development projects, with emphasis on design control and risk management. Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities. Contribute to quality improvement initiatives and ensure compliance with regulations and standards (FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead quality system). Plan and implement approved quality improvement actions and deliverables. Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex issues related to drug-device combination products, processes, and quality. Act as an escalation point for complex and high-impact quality issues, concerns, and decisions. Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs). Provide guidance and impact assessments for change controls, including DHF and RMF assessments. Develop and/or review controlled documents (protocols, reports, plans, risk analyses, specifications, test methods). Basic Qualifications
Bachelor's degree in engineering or a scientific discipline with at least 6 years of relevant experience, OR a Master’s degree with at least 4 years of relevant experience. Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products. Excellent verbal, written, and interpersonal communication skills. Preferred Qualifications
Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred. Strong project management and process improvement skills. Understanding of domestic and international quality system regulations and the ability to drive continuous improvement. Foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, GageR&R), and risk management per ISO 14971 (FMEA and systems analysis). Expertise in one of these areas is required. Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles. Strong knowledge of medical devices or combination products manufacturing. Compensation and Benefits The salary range for this position is $136,340.00 – $176,440.00. Base compensation is determined by factors including experience, qualifications, and location. This may include discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package (medical, dental, vision, and life insurance). For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants protected by applicable laws. For more information, view the Know Your Rights poster. Job Details
Seniority level: Not Applicable Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Senior Quality Engineer I - Combination Product Development
role at
Gilead Sciences .
Find out if this opportunity is a good fit by reading all of the information that follows below. At Gilead, we’re creating a healthier world. For more than 35 years, we’ve tackled diseases and developed therapies to improve lives and to ensure access to these therapies globally. We seek motivated people who will contribute to our mission with collaboration and determination. Key Responsibilities
Serve as a lead quality engineer for medical device combination product development projects, with emphasis on design control and risk management. Collaborate with device engineering on new combination product development, supporting design verification, validation, and transfer activities. Contribute to quality improvement initiatives and ensure compliance with regulations and standards (FDA 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and Gilead quality system). Plan and implement approved quality improvement actions and deliverables. Interface with internal stakeholders, contract manufacturers, and suppliers to resolve complex issues related to drug-device combination products, processes, and quality. Act as an escalation point for complex and high-impact quality issues, concerns, and decisions. Support strategic relationships with internal cross-functional teams and contract manufacturing organizations (CMOs). Provide guidance and impact assessments for change controls, including DHF and RMF assessments. Develop and/or review controlled documents (protocols, reports, plans, risk analyses, specifications, test methods). Basic Qualifications
Bachelor's degree in engineering or a scientific discipline with at least 6 years of relevant experience, OR a Master’s degree with at least 4 years of relevant experience. Demonstrated knowledge and experience in quality assurance for the development of medical devices and/or drug-device combination products. Excellent verbal, written, and interpersonal communication skills. Preferred Qualifications
Prior experience with combination products (e.g., autoinjectors, co-packed kits, pre-filled syringes) is preferred. Strong project management and process improvement skills. Understanding of domestic and international quality system regulations and the ability to drive continuous improvement. Foundation in statistical techniques (e.g., normality tests, capability analysis, tolerance intervals), test method validation (MSA, GageR&R), and risk management per ISO 14971 (FMEA and systems analysis). Expertise in one of these areas is required. Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles. Strong knowledge of medical devices or combination products manufacturing. Compensation and Benefits The salary range for this position is $136,340.00 – $176,440.00. Base compensation is determined by factors including experience, qualifications, and location. This may include discretionary annual bonus, stock-based long-term incentives, paid time off, and a benefits package (medical, dental, vision, and life insurance). For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing Equal Employment Opportunity Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information, gender identity and expression, veteran status, or other protected characteristics. Reasonable accommodations are available for applicants protected by applicable laws. For more information, view the Know Your Rights poster. Job Details
Seniority level: Not Applicable Employment type: Full-time Job function: Quality Assurance Industries: Biotechnology Research and Pharmaceutical Manufacturing
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