Sr Quality Engineer – Medical Device
2 weeks ago
Sr Quality Engineer – Medical Device Location: Santa Ana, California (Fully onsite) Type: W2 contract Duration: 12 months Must‑Have Experience with Nonconformance material reports, CAPAs, and FMEA. 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry. Work in a team environment and cross‑collaboration with multiple functional groups. Education Required Bachelor’s degree in Engineering, Science, or a related technical field. Position Overview As a Quality Engineer, you will play a key role in ensuring that products and processes comply with regulatory requirements. You’ll collaborate cross‑functionally to drive continuous improvement, support manufacturing, and ensure the highest levels of product quality and patient safety. The role includes hands‑on support in controlled environments, involvement with animal‑origin tissue, and active participation in daily production activities. Key Responsibilities Provide quality engineering support for manufacturing, sustaining, and new product introduction. Participate in daily manufacturing tier meetings to support production and address quality‑related concerns. Be present in controlled environment areas/clean rooms to monitor processes, support investigations, and ensure compliance with quality standards. Work with tissue from animal origin (porcine and bovine) in accordance with safety and regulatory requirements. Investigate product non‑conformances and implement corrective and preventive actions (CAPA). Lead or participate in process validation activities (IQ/OQ/PQ). Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations. Review and approve process and product changes. Analyze data, conduct risk assessments, and support root cause analysis. Lead or support internal and external audits. Participate in the development and review of quality documentation (procedures, protocols, reports). Qualifications Bachelor’s degree in Engineering, Science, or a related technical field. 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry. Experience with Nonconformance material reports, CAPAs, and FMEA. Able to work with Bovine and Porcine tissue. Working knowledge of FDA regulations and ISO 13485. Preferred Qualifications Experience with CAPA, risk management (FMEA), and process validation. ASQ certification (CQE, CQA) is a plus. Strong communication and teamwork skills. Experience with statistical analysis and data interpretation. #J-18808-Ljbffr
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Sr Quality Engineer
1 week ago
Santa Ana, United States Artech Full timeJob Title: Sr. Quality EngineerJob ID: 22904Location: 1851 E. Deere Ave, Santa Ana, CA 92705 (Onsite - Full Time)Duration: 12 MonthsPay Rate: $55.00 - $58.00/hr (W2)Summary:Seeking an experienced Sr. Quality Engineer to support manufacturing, sustaining, and new product introduction activities at Medtronic's Santa Ana site. The role focuses on driving...
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Sr Quality Engineer
6 days ago
Santa Ana, CA, United States Artech Full timeJob Title: Sr. Quality Engineer Job ID: 22904 Location: 1851 E. Deere Ave, Santa Ana, CA 92705 (Onsite - Full Time) Duration: 12 Months Pay Rate: $55.00 - $58.00/hr (W2) Summary: Seeking an experienced Sr. Quality Engineer to support manufacturing, sustaining, and new product introduction activities at Medtronic's Santa Ana site. The role focuses on driving...
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Sr Quality Engineer
2 weeks ago
Santa Ana, CA, United States Artech Full timeJob Title: Sr. Quality Engineer Job ID: 22904 Location: 1851 E. Deere Ave, Santa Ana, CA 92705 (Onsite - Full Time) Duration: 12 Months Pay Rate: $55.00 - $58.00/hr (W2) Summary: Seeking an experienced Sr. Quality Engineer to support manufacturing, sustaining, and new product introduction activities at Medtronic's Santa Ana site. The role focuses on driving...
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Sr Quality Engineer
1 week ago
Santa Ana, CA, United States Artech Full timeJob Title: Sr. Quality Engineer Job ID: 22904 Location: 1851 E. Deere Ave, Santa Ana, CA 92705 (Onsite - Full Time) Duration: 12 Months Pay Rate: $55.00 - $58.00/hr (W2) Summary: Seeking an experienced Sr. Quality Engineer to support manufacturing, sustaining, and new product introduction activities at Medtronic's Santa Ana site. The role focuses on driving...
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Sr Quality Engineer
5 days ago
Santa Ana, CA, United States Artech Full timeJob Title: Sr. Quality Engineer Job ID: 22904 Location: 1851 E. Deere Ave, Santa Ana, CA 92705 (Onsite - Full Time) Duration: 12 Months Pay Rate: $55.00 - $58.00/hr (W2) Summary: Seeking an experienced Sr. Quality Engineer to support manufacturing, sustaining, and new product introduction activities at Medtronic's Santa Ana site. The role focuses on driving...
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Santa Clara, United States Johnson & Johnson Full timeA leading healthcare company is seeking a Sr. Supplier Quality Engineer in Santa Clara, California. The role involves addressing quality issues with suppliers, providing support for manufacturing operations, and engaging in process improvements. Ideal candidates should have a BS or MS in engineering and relevant experience in the medical device industry. The...
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Santa Clara, United States Johnson & Johnson Full timeA leading healthcare company is seeking a Sr. Supplier Quality Engineer in Santa Clara, California. The role involves addressing quality issues with suppliers, providing support for manufacturing operations, and engaging in process improvements. Ideal candidates should have a BS or MS in engineering and relevant experience in the medical device industry. The...
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Santa Clara, United States Johnson & Johnson Full timeA leading healthcare company in Santa Clara is seeking a Sr Quality Engineer who will support manufacturing processes and ensure adherence to quality standards. The ideal candidate will have significant experience in the medical device industry, strong technical writing skills, and a proactive attitude. Responsibilities include analyzing nonconformance...
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Quality Engineer Medical Device
2 weeks ago
Santa Clarita, United States Blue Bridge People Full timeGet AI-powered advice on this job and more exclusive features. This range is provided by Blue Bridge People. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $55.00/hr - $70.00/hr Quality Engineer – Medical Devices (Design Assurance, Contract) Valencia, CA (Hybrid – minimum 3 days...
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Sr. Quality Engineer- Shockwave Medical
20 hours ago
Santa Clara, United States Johnson & Johnson MedTech Full timeSr. Quality Engineer – Shockwave Medical Johnson & Johnson MedTech is hiring a Sr. Quality Engineer for Shockwave Medical Inc. located in Santa Clara, CA. Apply via the Johnson & Johnson careers site. Position Overview: The Sr. Quality Engineer will support manufacturing and work cross‑functionally to resolve technical problems. Participates in decisions...
