Position: Product Quality Engineer Medical Device
Position Code: JNTC-SR-130111b
Location: South Bay Area, CA
Reports To: Engineering Manager
JNTC Careers is seeking a highly experienced and seasoned Product Quality Engineer of Medical Devices, with passion, being analytical with architectural design, development, testing, and maintenance of Flat Panel Displays and related hardware. Our client is focused exclusively on highest quality, most reliable medical devices products for medical industry and environments.
This position will play a key role in improving, creating and maintaining product quality and process improvement initiatives throughout the company. It is responsible in maintaining and deploying medical-imaging quality management system and production processes. These equipments provide best-in-class rendering of medical images for medical professional users in hospitals and clinics.
- Maintain medical imaging production processes and work instructions to support Production and Quality teams in building and testing products
- Provide support to Production and Quality teams in following approved production processes to meet company business goals, improve product First Pass Yield (FPY) and Customer Satisfaction
- Perform in-process Quality Control Audit, product testing and FPY measurement
- Collect process and product quality data; apply statistical process control method to measure effectiveness of production process and quality management system
- Conduct Internal, Supplier audits and identify areas that need improvement
- Collaborate with Engineering, Operations to facilitate new product introduction in Manufacturing
- Identify and implement Corrective and Preventive actions for continuous improvements
- Facilitate company Management Review, Preventive and Corrective Action, Customer Complaints, and Supplier Performance Reviews
- Facilitate Nonconforming material (NCR) and Material Review Board (MRB) activities
- Report significant issues identified during quality assurance activities. Reported issues should be associated with recommended corrective action or process improvement
- Qualify and implement alternative manufacturing materials, processes, tools to address quality and production efficiency concerns
- Work with customers, suppliers and management at all levels to address quality related concerns
- Act as Technical Liaison between Engineering and Production teams to investigate and resolve production technical issues on the floor
- Experienced in Quality Assurance & Control of medical device (at PCBA and box build levels).
- Quality Control Audit, product testing and FPY measurement
- Strong familiarity of medical device regulations (FDA 21 CFR 11, 820), international regulations and standards, ISO 13485 required
- Experienced in assembly/test operations, supplier qualification, incoming and final inspection
- Strong communication and skills in presenting and interpret Quality System documents, Engineering drawings and work instructions
- Experienced in product quality data; apply statistical process control method to measure effectiveness of production process and quality management system
- Experienced in conducting audits internally, supplier audits for improvement
- Abilities to collaborate with Engineering, Operations to facilitate new product introduction in Manufacturing.
- Experienced to identify and implement Corrective and Preventive actions for continuous improvements.
- Experienced in Management Review, Preventive and Corrective Action, Customer Complaints, and Supplier Performance Reviews
- Experienced to qualify and implement alternative manufacturing materials, processes, tools to address quality and production efficiency concerns
- Experienced to develop, update quality management system processes and work instructions
- Problem solving abilities to address at all levels the quality related concerns with customers, suppliers and management
Candidate Qualifications & Competencies:
- BSEE or BSCE
- 5+ years of experiences in Quality Assurance & Control of medical device
- Supervisory experienced with multi-task ability
- Ability to work in a very fast paced environment
- Demonstrable computer proficiency with MS Office. Great Plains experienced desirable.
- Familiarity with non-compliance trending statistical analysis methodology and tools
- Strong knowledge of defect/issue/complaint handling process and tools.
- DOE (Depending On Experience)
- Plus Corporate Basic Benefits
Submitting Your Candidacy:
- Please submit your resume in word file (.doc) to email@example.com
- Please put the following into your subject line: Full Name + Position Code: JNTC-SR-130111b (Product Quality Engr MedDev)
- All qualifying candidates will be interviewed by telephone for screening purposes. Succeeding steps will follow to those who will become strong candidate for this position.
- When your qualification will not match to all of the requirements of this position, your Resume will be put in our active database for future consideration of any employment opportunity. Thank you.