- Conduct quality inspections on incoming items, in-process production items, and finished products to ensure compliance with quality standards and specifications.
- Collaborate with production teams and Quality Engineering teams to improve quality inspection procedures and processes.
- Utilize quality systems and tools to track, analyze, and report on quality metrics.
- Initiate and drive to completion thorough and correct nonconformance reports when quality issues are identified.
- Coordinate with Supplier Quality and Supply Chain to resolve issues identified in quality inspection activities.
- Support Quality Engineers in the conduct of root cause analysis and associated activities to address quality issues.
- High school diploma or GED required. Bachelor's degree (BS) in relevant science or engineering field preferred.
- Five (5) years of experience working within medical device or pharmaceutical quality management systems (QMS), optimally with direct responsibilities for performing receiving inspection, in-process inspection, and finished product inspection.
- Experience conducting quality inspections using various measurement tools and equipment, as well as reviewing paper and/or electronic documents and records including specifications, certificates of analysis, certificates of compliance, quality control test results, and device history records in compliance with standard operating procedures and work instructions.
- Working knowledge and implementation of applicable medical device regulations and standards including but not limited to 21 CFR 820, ISO 13485, ISO 14971, MDR / IVDR.
- Demonstrated expertise initiating and completing nonconformance reports and providing guidance and oversight to ensure appropriate segregation, identification, and ultimate material disposition (physical and electronic).
- Experience working with software applications such as Enterprise Resource Planning (ERP), Laboratory Information Management Systems (LIMS), electronic quality management systems (eQMS), document management systems, and related tools.
- Ability to analyze data and generate reports to communicate quality trends and issues.
- Strong written and verbal communication skills.
- Ability to comprehend and interpret technical information related to analytical methods, processes, and regulatory requirements
- Leadership or supervisory experience in receiving inspection and internal acceptance activities.
- ASQ Certified Quality Technician, Certified Quality Engineer, or similar.
-
Quality Technician
2 weeks ago
R. C. TWAY COMPANY, LLC University Park, United StatesR. C. TWAY COMPANY, LLC · Come join a team where People make the difference As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attr ...
-
Quality Technician
1 week ago
IMI Norgren University Park, United States**IMI plc** · We are a global specialist engineering company that creates breakthrough solutions. We are curious and like to solve problems, partnering with our customers to solve the demands of today and prepare for the challenges of tomorrow. We embrace innovation and care abou ...
-
Quality Engineering Technician
1 week ago
Joby Aviation San Carlos, United StatesJoby Overview: Located in Northern California, the Joby Aviation team is steadily working toward our goal of creating an affordable, all-electric air transportation system. Imagine an air taxi that takes off vertically, then quietly and quickly carries you over the traffic conges ...
-
Quality Engineering Technician Iii
4 days ago
Pulmonx Corporation Redwood City, United States**Pulmonx** is looking for a **Quality Engineering Technician III** to join and our team Who is **Pulmonx**? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · **Resp ...
-
Quality Technician
1 week ago
Actalent Milpitas, United States Full timeGreat opportunity to join a dynamic team developing a cutting edge technology within biotech · Essential Duties: · • Sample preparation for the laboratory · • Assist with performing equipment validation (IQ/OQ/PQ) including writing the protocols and reports. · • Maintain quality ...
-
Quality Technician Ii
1 week ago
Thermo Fisher Scientific Sunnyvale, United StatesWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your car ...
-
Quality Assurance Technician
1 week ago
Petit Pot Emeryville, United StatesAbout Petit Pot · In 2014, while trying to find the perfect dessert to go with dinner, French pastry chef Maxime realized something was missing in his local grocery store: Pot de crème As a fan of all things sweet, Maxime decided to address this craving by founding Petit Pot in S ...
-
Rma Quality Technician
3 days ago
Atlona San Jose, United States**Summary/Objective**: · Atlona is currently looking for a RMA Quality Technician to perform inspections and calibrations on Video Matrix Switchers, AVoIP and Control Systems. You will be maintaining the day-to-day activities of the calibration/RMA lab, ensure the company's RMA p ...
-
Quality Technician
1 day ago
Manpower Engineering San Carlos, United States TemporaryOur client, a leading an autonomous vehicle company, is seeking a Quality Technician to join their team. As a Quality Technician, you will be part of the Manufacturing Operations Department supporting the development of various sensor technologies and compute platforms for automo ...
-
Specialist Technician, Quality Control
3 weeks ago
Johnson & Johnson Santa Clara, United StatesAuris Health a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist Technician, Quality Control located in Santa Clara, CA. · **Responsibilities**: · - Strictly adhere to quality control procedures and guidelines to determine product conformity · - In ...
-
Quality Assurance Technician I
3 weeks ago
Rotisystems Oakland, United StatesGeneral Description · This position is responsible for the inspection and testing of manufacturing processes and products to ensure the product safety and quality. Daily tasks include routine quality checks, QA inspection, record keeping, CCPs monitoring, equipment calibration, a ...
-
Quality Control/Warehouse Technician
1 week ago
Inscopix Stanford, United States**Quality Control/Warehouse Technician (Temp to Hire)** · at Inscopix Inc Palo Alto, CA Inscopix, a discovery phase neurotechnology company, is seeking an experienced, dedicated and self-motivated Quality Control Technician to join our team. In this position, the QC Technician w ...
-
Quality Control Technician- 1st Shift
3 weeks ago
Vanee Foods Company Berkeley, United StatesPre · - Operational/Operational · - Perform Pre-Operational Inspection of equipment by visually checking for residue remaining from previous production · - Tag equipment that has failed inspection and communicate issues with Sanitation Supervisor and/or Sanitation Foreman · - Ver ...
-
Quality Engineering Technician III
1 week ago
Blackwomenintech Redwood City, United StatesPulmonx · is looking for a · Quality Engineering Technician III · to join and our team Who is · Pulmonx ? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · Resp ...
-
Quality Engineering Technician III
1 week ago
Pulmonx Redwood City, United StatesPulmonx · is looking for a · Quality Engineering Technician III · to join and our team Who is · Pulmonx ? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · Respo ...
-
Quality Engineering Technician III
1 week ago
Pulmonx Redwood City, United StatesPulmonx is looking for a Quality Engineering Technician III to join and our team Who is Pulmonx? We are the maker of the Zephyr Endobronchial Valve and a global leader in interventional pulmonology, planning tools, and treatments for obstructive lung disease. · If you think you ...
-
Quality Engineering Technician
1 week ago
Joby Aviation San Carlos, United StatesJoby Overview: · Located in Northern California, the Joby Aviation team is steadily working toward our goal of creating an affordable, all-electric air transportation system. Imagine an air taxi that takes off vertically, then quietly and quickly carries you over the traffic con ...
-
Quality Engineering Technician
1 week ago
Joby Aviation San Carlos, United States Regular Full timeOverview · Joby Aviation is seeking a highly organized, passionate individual to join our quality engineering team. As part of this team, you will be responsible for performing inspections on complex parts and assemblies to ensure that they meet engineering specifications a ...
-
quality technician
3 weeks ago
Randstad Sunnyvale, United Statesquality technician. · sunnyvale , california · posted 6 days ago · job details · summary · $ $39.31 per hour · contract · associate degree · category computer and mathematical occupations · reference · job details · job summary: · A Quality Technician is needed for a biome ...
-
Quality Technician
4 weeks ago
Randstad USA Sunnyvale, United States Freelance, Full timejob summary: · A Quality Technician is needed for a biomedical/biotechnology engineering firm and multinational manufacturer of medical devices in the Sunnyvale, CA area. The role involves conducting investigations on returned products, disinfecting them for analysis, ensuring co ...
Senior Quality Technician - Menlo Park, United States - Randstad Life Sciences US
Description
Exciting opportunity for a Senior Quality Technician to work with a growing biotechnology company focused on cancer screening and detection.
Primary responsibilities include completing required document reviews and material inspections, completing associated forms and other documents as part of Standard Operating Procedures and Work Instructions process requirements, in compliance with the EU In Vitro Diagnostic Regulation (IVDR), ISO 13485, ISO 14971, FDA 21 CFR 820 and related medical device regulations.
This individual is responsible for executing acceptance activities associated with receiving inspection and release of purchased items, and finished product inspection of internally manufactured items. These items (i.e., components, raw materials, and finished reagents) are processed in accordance with our medical device and clinical laboratory quality management system requirements. This person works closely with Supply Chain, Manufacturing Science & Technology (MSAT), Quality Control (QC), Development, Design Quality, and other teams to ensure compliance with procedures and product quality assurance is maintained. The person in this role consistently applies critical thinking skills and good judgment to solve focused problems.
Schedule/Shift: 1st shift, Mon.-Fri. 7:00/8:00am-4:00/5:00pm
Position Type: Contract-to-hire role
Essential Duties and Responsibilities:
Qualifications:
Preferred Skills and Experience:
