Johnson & Johnson
Senior Quality Engineering Shockwave Medical
Johnson & Johnson, Santa Clara, California, us, 95053
Johnson & Johnson is hiring for a
Senior Quality Engineer – Shockwave Medical
to join our team in
Santa Clara, CA . We are developing innovative treatments at the intersection of biology and technology, including the commercialization of Intravascular Lithotripsy (IVL) for complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to set new standards in treating atherosclerotic cardiovascular disease using proprietary sonic pressure waves. Position Overview The Senior Quality Engineer collaborates with internal departments to ensure the delivery of safe, effective medical devices, aligning with Shockwave Medical Inc. (SWMI) and Johnson & Johnson policies. This role supports hardware and software sustaining engineering activities, focusing on process improvements, design control compliance (ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366, IEC 60601), and quality assurance in manufacturing and development processes. Essential Job Functions Coordinate with contract manufacturers to maintain product quality and resolve non-conformances. Prepare documentation for inspection, testing, verification/validation protocols, quality plans, defect investigations, and inspection plans. Write clear, detailed technical documents for regulatory review; review and provide feedback on such documents. Evaluate and adapt standard techniques and procedures for complex engineering tasks. Guide manufacturing and development engineers on documentation, process controls, and quality practices. Perform assignments independently, understanding overall project expectations. Seek technical guidance for complex issues and obtain supervisory approval for project plans. Plan and coordinate engineering work within projects. Address complex design and manufacturing challenges, applying broad knowledge of related standards and regulations. Assess components and products for compliance, investigating non-conformances with multidisciplinary teams. Participate in design reviews, product transitions, and risk management updates (Hazard assessment, FMEA, etc.). Audit Design History Files (DHFs) for compliance. Manage Non-conformance Reports (NCR) and Corrective and Preventive Actions (CAPA). Review and approve Document Change Orders (DCO). Support internal and supplier audits; ISO 13485 lead auditor certification is advantageous. Handle customer complaints and coordinate servicing activities. Assist in regulatory submissions and product approvals. Apply statistical analysis skills (using Minitab) for process capability and data assessments. Uphold Johnson & Johnson’s Credo and Leadership Principles. Perform other duties as assigned. Requirements BS in engineering with 5+ years or MS with 3+ years of related experience. Preferred experience in the medical device industry. Strong technical writing and verbal communication skills. Experience with customer complaint investigations and reporting. Support for contract manufacturing as a Quality Engineer. Leadership in problem-solving and risk analysis. Proactive, self-motivated, with minimal supervision. Experience with design verification/validation protocols is a plus. Relevant certifications or licenses are advantageous. Willingness to travel minimally. Effective communication with all organizational levels. Attention to detail, proficiency in MS Office. Ability to work independently in a fast-paced environment. Johnson & Johnson is an Equal Opportunity Employer. We welcome applicants regardless of race, religion, gender, sexual orientation, age, or disability. For accommodations during the interview process, contact us via
our contact page . Salary Range:
$89,000 - $142,600 Additional benefits include medical, dental, vision, life insurance, disability coverage, retirement plans, paid time off, parental leave, and more. Details available at
https://www.careers.jnj.com/employee-benefits .
#J-18808-Ljbffr
Senior Quality Engineer – Shockwave Medical
to join our team in
Santa Clara, CA . We are developing innovative treatments at the intersection of biology and technology, including the commercialization of Intravascular Lithotripsy (IVL) for complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to set new standards in treating atherosclerotic cardiovascular disease using proprietary sonic pressure waves. Position Overview The Senior Quality Engineer collaborates with internal departments to ensure the delivery of safe, effective medical devices, aligning with Shockwave Medical Inc. (SWMI) and Johnson & Johnson policies. This role supports hardware and software sustaining engineering activities, focusing on process improvements, design control compliance (ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366, IEC 60601), and quality assurance in manufacturing and development processes. Essential Job Functions Coordinate with contract manufacturers to maintain product quality and resolve non-conformances. Prepare documentation for inspection, testing, verification/validation protocols, quality plans, defect investigations, and inspection plans. Write clear, detailed technical documents for regulatory review; review and provide feedback on such documents. Evaluate and adapt standard techniques and procedures for complex engineering tasks. Guide manufacturing and development engineers on documentation, process controls, and quality practices. Perform assignments independently, understanding overall project expectations. Seek technical guidance for complex issues and obtain supervisory approval for project plans. Plan and coordinate engineering work within projects. Address complex design and manufacturing challenges, applying broad knowledge of related standards and regulations. Assess components and products for compliance, investigating non-conformances with multidisciplinary teams. Participate in design reviews, product transitions, and risk management updates (Hazard assessment, FMEA, etc.). Audit Design History Files (DHFs) for compliance. Manage Non-conformance Reports (NCR) and Corrective and Preventive Actions (CAPA). Review and approve Document Change Orders (DCO). Support internal and supplier audits; ISO 13485 lead auditor certification is advantageous. Handle customer complaints and coordinate servicing activities. Assist in regulatory submissions and product approvals. Apply statistical analysis skills (using Minitab) for process capability and data assessments. Uphold Johnson & Johnson’s Credo and Leadership Principles. Perform other duties as assigned. Requirements BS in engineering with 5+ years or MS with 3+ years of related experience. Preferred experience in the medical device industry. Strong technical writing and verbal communication skills. Experience with customer complaint investigations and reporting. Support for contract manufacturing as a Quality Engineer. Leadership in problem-solving and risk analysis. Proactive, self-motivated, with minimal supervision. Experience with design verification/validation protocols is a plus. Relevant certifications or licenses are advantageous. Willingness to travel minimally. Effective communication with all organizational levels. Attention to detail, proficiency in MS Office. Ability to work independently in a fast-paced environment. Johnson & Johnson is an Equal Opportunity Employer. We welcome applicants regardless of race, religion, gender, sexual orientation, age, or disability. For accommodations during the interview process, contact us via
our contact page . Salary Range:
$89,000 - $142,600 Additional benefits include medical, dental, vision, life insurance, disability coverage, retirement plans, paid time off, parental leave, and more. Details available at
https://www.careers.jnj.com/employee-benefits .
#J-18808-Ljbffr