- Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements.
- Lead risk management activities, including hazard analysis, FMEAs, and risk documentation.
- Support sterilization and biocompatibility assessments.
- Own and maintain design control documentation.
- Partner with R&D, Regulatory, Manufacturing, and Project Management to ensure quality is built into every stage of product development.
- Maintain accurate test, validation, and risk records and report progress to leadership.
- Support regulatory submissions (e.g., 510(k), CE Mark).
- Lead root cause investigations and corrective actions related to design issues.
- Support complaint investigations, nonconformances, and CAPAs after product launch.
- Conduct DHF audits to ensure phase completion requirements are met.
- Review and approve engineering documents and test reports.
- Identify opportunities to improve product quality, reduce cost, and increase efficiency.
- Bachelor's degree in Engineering or related field.
- 10+ years of quality engineering experience in medical devices, including new product launches.
- Experience with sterilization and biocompatability
- Strong knowledge of design controls, risk management, and medical device regulations (FDA, ISO, IEC).
- Experience with verification & validation (V&V) and FMEAs.
- Strong problem-solving and statistical analysis skills (e.g., Minitab, JMP).
- Detail-oriented with strong documentation skills.
- Quality certifications (CQE, CSQE, Six Sigma) are a plus.
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Collins Aerospace is seeking a results-driven and detail-oriented Senior Product Quality Engineer to join our Product Quality team in Fairfield, CA. · ...
Sonoma $95,500 - $181,700 (USD)1 month ago
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Collins Aerospace is seeking a results-driven and detail-oriented Senior Product Quality Engineer to join our Product Quality team in Fairfield, CA. · ...
Sonoma, CA1 month ago
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The Quality Engineer will support the updating consolidation and migration of legacy product risk management files to ensure compliance with IVDR requirements. · Facilitate risk management assessments including updating risk management plans reports and system hazard analyses in ...
Hercules1 month ago
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This is an exciting opportunity to join a global industry leading company as Quality Engineer. The role involves facilitating risk management assessments and updating reports. · Facilitate risk management assessments. · Update risk plans and reports. · ...
Hercules1 month ago
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This is an exciting opportunity to join a global, industry leading company. · The Quality Engineer will help facilitate the updating and consolidation of legacy product risk management files related to IVDR.Facilitate risk management assessments, update risk plans and reports, co ...
Hercules, CA1 month ago
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Responsible for ensuring products meet internal quality standards and customer expectations throughout the production process and after delivery. · ...
Richmond $72,650 - $121,050 (USD)3 weeks ago
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The Quality Engineer will help facilitate the updating and consolidation of legacy product risk management files related to IVDR. · Facilitating risk management assessments, · coordinating meetings, · escalating events · ,supporting risk profile creation · aand identification of ...
Hercules $40.38 - $55.76 (USD)1 month ago
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We recruit top-notch talent for over 40 Fortune and Government clients coast-to-coast across the U.S. · ...
San Rafael3 weeks ago
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The Quality · Engineer will help facilitate the updating and consolidation of legacy product risk management files related to IVDR. · Bachelor's degree or equivalent in a related technical or engineering discipline · 2-3 years experience or equivalent combination of education an ...
Hercules, CA1 month ago
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The Calix Quality Team purpose is to drive organizational improvements, process adherence and product conformity benefiting both Broadband Service Providers (BSPs) and Calix Stakeholders. In this Quality Engineering role, you will identify hardware return trends, drive the struc ...
Petaluma $123,000 - $240,400 (USD) Full time1 month ago
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· Company Description · Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies ...
Richmond, CA $80,000 - $145,000 (USD) per year1 day ago
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Worker Type · Contractor · Summary · Job Description · The Quality Engineer II (QE) is accountable for the overall delivered quality of products and/or services to customers and ensures quality controls are met. The QE engages Continuous Improvement (CI) resources to identify and ...
Petaluma3 days ago
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Worker Type · Contractor · Job Description · Summary · The Quality Engineer II (QE) is accountable for the overall delivered quality of products and/or services to customers and ensures quality controls are met. The QE engages Continuous Improvement (CI) resources to identify and ...
Petaluma Full time3 days ago
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Worker Type · Regular · Job Description · Summary · The Quality Engineer II (QE) is accountable for the overall delivered quality of products and/or services to customers and ensures quality controls are met. The QE engages Continuous Improvement (CI) resources to identify and el ...
Petaluma $82,000 - $116,025 (USD) Full time6 days ago
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Worker Type · Regular · Summary · Job Description · The Quality Engineer II (QE) is accountable for the overall delivered quality of products and/or services to customers and ensures quality controls are met. The QE engages Continuous Improvement (CI) resources to identify and el ...
Petaluma $82,000 - $116,025 (USD)6 days ago
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The Calix Quality Team purpose is to drive organizational improvements, process adherence and product conformity benefiting both Broadband Service Providers (BSPs) and Calix Stakeholders. · ...
Petaluma, CA1 month ago
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Worker Type · Regular · Summary · Job Description · The Quality Engineer II (QE) is accountable for the overall delivered quality of products and/or services to customers and ensures quality controls are met. The QE engages Continuous Improvement (CI) resources to identify and el ...
Petaluma, CA6 days ago
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Worker Type · Regular · Job Description · Summary · The Quality Engineer II (QE) is accountable for the overall delivered quality of products and/or services to customers and ensures quality controls are met. The QE engages Continuous Improvement (CI) resources to identify and el ...
Petaluma, CA5 days ago
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Responsibilities: · Ensure all design control activities for new and updated products meet company procedures and global regulatory requirements. · Lead risk management activities, including hazard analysis, FMEAs, and risk documentation. · Support sterilization and biocompatibi ...
Santa Rosa $90,000 - $155,000 (USD) per year12 hours ago
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Experience in JAVA, Selenium, REST, SOAP Strong in Coding. · ...
San Rafael3 weeks ago
Design Quality Engineer - Sonoma - SciPro
Description
Responsibilities:
Requirements
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Senior Product Quality Engineer
Only for registered members Sonoma
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Senior Product Quality Engineer
Only for registered members Sonoma, CA
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Quality Engineer
Only for registered members Hercules
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Quality Engineer
Only for registered members Hercules
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Quality Engineer
Only for registered members Hercules, CA
-
Quality Engineer
Only for registered members Richmond
-
Quality Engineer
Only for registered members Hercules
-
Quality Engineer
Only for registered members San Rafael
-
Quality Engineer
Only for registered members Hercules, CA
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Staff Quality Engineer
Full time Only for registered members Petaluma
-
Quality Engineer
Only for registered members Richmond, CA
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Quality Engineer II
Only for registered members Petaluma
-
Quality Engineer II
Full time Only for registered members Petaluma
-
Quality Engineer II
Full time Only for registered members Petaluma
-
Quality Engineer II
Only for registered members Petaluma
-
Staff Quality Engineer
Only for registered members Petaluma, CA
-
Quality Engineer II
Only for registered members Petaluma, CA
-
Quality Engineer II
Only for registered members Petaluma, CA
-
Design Quality Engineer
SciPro- Santa Rosa
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Quality Engineer with Selenium
Only for registered members San Rafael
