TalentBurst, an Inc 5000 company
TalentBurst, an Inc 5000 company provided pay range
This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$130,000.00/yr - $160,000.00/yr Position: Senior Quality Engineer, Req#: 1022 Location: Fremont, CA (100% Onsite) Job Description: The Senior Quality Engineer is responsible for the quality, safety, and reliability of the client’s products. This role requires expertise in supplier, design, manufacturing, and software quality engineering. The engineer must demonstrate an understanding of consumables and sterilization processes. The Senior Quality Engineer must have a deep understanding and ability to effectively and efficiently apply the applicable requirements, such as the Quality System Regulation (21 CFR 820) and ISO 13485. They must have a passion to spearhead and lead the effort to develop, maintain, and continuously improve our standard practices while proactively providing cross-functional support. This individual will act as the Quality representative on current and/or new product development, taking initiative to influence, coach, and mentor teams appropriately. An ideal candidate will have a high level of technical skill and depth of knowledge to support the development of complex medical robotics. Other responsibilities include supporting products throughout all development phases, test protocol development, process qualification/validation activities, the creation of statistically sound sampling plans, product investigations, and other quality processes. This position is based in the Fremont, CA, Office. Education and Experience (Required): Bachelor’s degree (or equivalent experience) with 7 plus years of related experience. Ability to manage priorities and workflow in a rapidly changing environment. Proven experience in design for reliability, manufacturability, and serviceability. Proven experience managing quality in supplier, design, manufacturing, and software engineering environments. Demonstrated understanding of Medical Device QMS requirements and regulatory requirements, including but not limited to FDA CFR 21 820 and ISO 13485. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, and production process control methodologies in a medical device environment. Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment. Job Responsibilities: Proactively investigate, identify, and implement best-in-class Quality Engineering practices. Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Work with product development teams to develop measurable goals for quality. Participate in the risk management process, ensuring, when applicable, that hazards are adequately mitigated in product and process quality plans in accordance with the client procedures and external standards (e.g., EN 14971). Participate in Usability Engineering and planning documentation (e.g., EN 62366/ISO 62366). Contribute to software documentation according to IEC62304, biocompatibility testing according to applicable regulations and standards, including ISO10993, and EMC testing according to IEC60601-1. Guide other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the client’s products. Support new product introduction projects through the development and execution of process validation and verification test plans, protocols, and reports. Plan and direct the creation of quality standards, quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Quality Engineer jobs in
Fremont, CA . Fremont, CA $90,000.00-$100,000.00 1 month ago Mountain View, CA $196,000.00-$248,000.00 1 week ago Palo Alto, CA $196,000.00-$208,000.00 2 weeks ago Pleasanton, CA $105,000.00-$120,000.00 3 days ago Fremont, CA $90,000.00-$100,000.00 1 month ago San Jose, CA $100,000.00-$130,000.00 5 days ago San Jose, CA $159,800.00-$202,300.00 1 week ago Pleasanton, CA $105,000.00-$120,000.00 3 days ago Santa Clara, CA $108,000.00-$224,250.00 5 days ago Fremont, CA $72,000.00-$94,000.00 2 days ago San Jose, CA $110,000.00-$135,000.00 4 days ago Fremont, CA $75,000.00-$95,000.00 1 week ago Mountain View, CA $150,000.00-$200,000.00 2 weeks ago Supplier Quality Engineer, Body in White
Staff Supplier Quality Engineer - Mechanical (Remote or Hybrid)
San Jose, CA $141,280.00-$211,920.00 1 week ago Staff Quality Engineer, Optimus Manufacturing
Redwood City, CA $112,700.00-$155,000.00 2 weeks ago San Mateo, CA $140,000.00-$180,000.00 2 weeks ago San Jose, CA $120,000.00-$150,000.00 2 weeks ago Staff Supplier Quality Engineer - Mechanical
San Jose, CA $130,000.00-$154,000.00 1 week ago Fremont, CA $223,163.00-$231,110.00 15 hours ago Pleasanton, CA $135,500.00-$183,300.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range
$130,000.00/yr - $160,000.00/yr Position: Senior Quality Engineer, Req#: 1022 Location: Fremont, CA (100% Onsite) Job Description: The Senior Quality Engineer is responsible for the quality, safety, and reliability of the client’s products. This role requires expertise in supplier, design, manufacturing, and software quality engineering. The engineer must demonstrate an understanding of consumables and sterilization processes. The Senior Quality Engineer must have a deep understanding and ability to effectively and efficiently apply the applicable requirements, such as the Quality System Regulation (21 CFR 820) and ISO 13485. They must have a passion to spearhead and lead the effort to develop, maintain, and continuously improve our standard practices while proactively providing cross-functional support. This individual will act as the Quality representative on current and/or new product development, taking initiative to influence, coach, and mentor teams appropriately. An ideal candidate will have a high level of technical skill and depth of knowledge to support the development of complex medical robotics. Other responsibilities include supporting products throughout all development phases, test protocol development, process qualification/validation activities, the creation of statistically sound sampling plans, product investigations, and other quality processes. This position is based in the Fremont, CA, Office. Education and Experience (Required): Bachelor’s degree (or equivalent experience) with 7 plus years of related experience. Ability to manage priorities and workflow in a rapidly changing environment. Proven experience in design for reliability, manufacturability, and serviceability. Proven experience managing quality in supplier, design, manufacturing, and software engineering environments. Demonstrated understanding of Medical Device QMS requirements and regulatory requirements, including but not limited to FDA CFR 21 820 and ISO 13485. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, and production process control methodologies in a medical device environment. Previous work experience with product design changes, process verification and validation, as well as production process controls methodologies in an FDA/ISO regulated environment. Job Responsibilities: Proactively investigate, identify, and implement best-in-class Quality Engineering practices. Provide quality engineering expertise in supplier management, design control, manufacturing, software quality, and sterilization activities. Provide focused quality engineering support and assume responsibility for timely and effective coordination and/or execution of assigned development project activities. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices. Work with product development teams to develop measurable goals for quality. Participate in the risk management process, ensuring, when applicable, that hazards are adequately mitigated in product and process quality plans in accordance with the client procedures and external standards (e.g., EN 14971). Participate in Usability Engineering and planning documentation (e.g., EN 62366/ISO 62366). Contribute to software documentation according to IEC62304, biocompatibility testing according to applicable regulations and standards, including ISO10993, and EMC testing according to IEC60601-1. Guide other engineers regarding applicable regulatory and statutory requirements and the applicability of these requirements to the client’s products. Support new product introduction projects through the development and execution of process validation and verification test plans, protocols, and reports. Plan and direct the creation of quality standards, quality control and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices manufactured. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at TalentBurst, an Inc 5000 company by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Quality Engineer jobs in
Fremont, CA . Fremont, CA $90,000.00-$100,000.00 1 month ago Mountain View, CA $196,000.00-$248,000.00 1 week ago Palo Alto, CA $196,000.00-$208,000.00 2 weeks ago Pleasanton, CA $105,000.00-$120,000.00 3 days ago Fremont, CA $90,000.00-$100,000.00 1 month ago San Jose, CA $100,000.00-$130,000.00 5 days ago San Jose, CA $159,800.00-$202,300.00 1 week ago Pleasanton, CA $105,000.00-$120,000.00 3 days ago Santa Clara, CA $108,000.00-$224,250.00 5 days ago Fremont, CA $72,000.00-$94,000.00 2 days ago San Jose, CA $110,000.00-$135,000.00 4 days ago Fremont, CA $75,000.00-$95,000.00 1 week ago Mountain View, CA $150,000.00-$200,000.00 2 weeks ago Supplier Quality Engineer, Body in White
Staff Supplier Quality Engineer - Mechanical (Remote or Hybrid)
San Jose, CA $141,280.00-$211,920.00 1 week ago Staff Quality Engineer, Optimus Manufacturing
Redwood City, CA $112,700.00-$155,000.00 2 weeks ago San Mateo, CA $140,000.00-$180,000.00 2 weeks ago San Jose, CA $120,000.00-$150,000.00 2 weeks ago Staff Supplier Quality Engineer - Mechanical
San Jose, CA $130,000.00-$154,000.00 1 week ago Fremont, CA $223,163.00-$231,110.00 15 hours ago Pleasanton, CA $135,500.00-$183,300.00 5 days ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr