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Medical Device Technician
1 week ago
ATR International Alameda, United StatesJob Description · Job DescriptionSwing 1:30PM - 10PM · We are seeking a Complaint Investigations Tech for a very important client. · Responsible for implementing and maintaining the effectiveness of the quality system. Perform routine testing (physical, chemical or functional) on ...
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Medical Device Project Manager
2 weeks ago
INFOTRON Los Altos, United States**Job Summary** · We are hiring a Project/Portfolio Manager for a client that designs and manufactures highly complex surgical systems including cameras, instruments, and accessories for use in surgery. You will manage Robotic Assisted Surgical Devices projects associated with th ...
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Quality Engineer Medical Devices
1 week ago
QAPEL MEDICAL INC Fremont, United StatesJob Description · Job Description · About Q'Apel: · At Q'Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we're a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical need ...
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Quality Engineer Medical Devices
1 week ago
QAPEL MEDICAL INC Fremont, United StatesJob Description · Job DescriptionAbout Q'Apel: · At Q'Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we're a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. ...
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Lead Medical Device Technical Writer
3 weeks ago
Ledgent Technology Fremont, United StatesMedical Device client is seeking a Lead R&D Technical Writing Analyst - Hybrid in Fremont, CA · Pay Rate Range: $60.00/hr. - $73.33/hr. · 12+month contract · Description/Comment: · As part of Sustaining R&D, the Lead Analyst, R&D Technical Writing is responsible for creating end- ...
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Head of Medical Devices, Hcls, Amer Industries
2 weeks ago
Amazon Web Services, Inc. Santa Clara, United States5+ years of developing, negotiating and executing business agreements experience · - 5+ years of professional or military experience · - Bachelor's degree · - Experience developing strategies that influence leadership decisions at the organizational level · - Experience managing ...
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Medical Device
2 weeks ago
MetaOps, Inc San Francisco, United StatesJob Description · Job DescriptionMetaExperts is proactively seeking candidates to be considered for roles with our growing nationwide customer base for contracting and contract-to-hire opportunities in the medical device/equipment, bioscience and pharma industry. The kinds of rol ...
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QAPEL MEDICAL INC Fremont, United StatesJob Description · Job DescriptionAbout Q'Apel: · At Q'Apel, we are passionate about revolutionizing neurovascular access. We design novel access device technologies for vascular interventions and unmet clinical needs. In the precious seconds that surround a stroke emergency, clin ...
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Medical Device Assembler
2 weeks ago
Spherion Milpitas, United StatesOur Milpitas Medical Device Client is seeking a Medical Device Assembler. · This is a 6 month contract to hire. · This is an On-Site role in Milpitas, CA · Day Shift 530am - 2:30pm · This is a new, full-time, Nonexempt, position. It is a temp to hire · JOB TITLE: Assembler · ESSE ...
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Medical Device Assembler
1 week ago
Axelon Services Corporation Pleasanton, United StatesJob Title : Medical Device Assembler I · Location : Pleasanton, CA · Shift Timings : 5:00 AM - 1:30 PM · Pay Rate : $21.50/hr · Job Description: "This is a non-exempt position. · This position is responsible for the production of high quality medical devices within a manufacturin ...
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Medical Device Assembler
3 weeks ago
ATR International Pleasanton, United StatesJob Description · Job DescriptionWe are seeking an Operator I for a very important client. · This position is responsible for the production of high quality medical devices within a manufacturing cell. Working under close supervision, may perform a combination of assembly, repair ...
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Medical Device Assembler
3 weeks ago
Aerotek Milpitas, United States OTHERHiring 5 experienced Catheter assemblers for a Medical Device Company in Milpitas, CA · Job Description: · • Assemble product as required utilizing small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures. · • Processes include: lamination, ...
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Medical Device Assembler
1 week ago
Bayside Solutions Redwood City, United StatesBayside Solutions is seeking a Medical Device Assembler to be a part of our Client' s team in Redwood City. Our Company Bio: Bayside Solutions was founded in 2001, and was recognized as one of the fastest growing professional staffing companies in No Medical, Assembler, Manufactu ...
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Medical Device Sales
6 days ago
SkillBridge, Inc San Francisco, United StatesMEDICAL DEVICE / SURGICAL SALES OPPORTUNITY · SAN FRANCISCO – "Sales Associate" · Great opportunity to land a medical device sales position with our client, a national leader in surgical devices, instruments and implants. No previous medical device sales a year of post college s ...
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Medical Device Engineer
1 week ago
Griffin Global Systems Inc San Francisco, United States2-3 Days remote/2-3 Days on-site · Required Experience: · Bachelor's degree in Electrical Engineering, Mechanical Engineering, or similar technical discipline with 3+ years of experience. Masters' Degree with 1+ years of related experience. · Safety testing within IEC 60601 serie ...
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Medical Device Engineer
3 weeks ago
MindSource South San Francisco, United States: The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics. · The candidate has technical expertise in the development and comm ...
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Medical Device Engineer
4 weeks ago
MindSource San Francisco, United States: The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics. · Have you got what it takes to succeed The following information s ...
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Manager, Medical Device
1 week ago
Experis South San Francisco, United StatesSenior Manager, Medical Device Technology, Complaint Handling · Our client in · South San Francisco · is looking for hardworking, motivated talent to join their team. · Don't wait... apply today · What's in it for you? · Pay range $85 - $92/hr/W2 · 100 %Onsite, Contract Full-Time ...
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Medical Device Engineer
3 weeks ago
MindSource South San Francisco, United States: · The Device Engineer II will be responsible for providing design, development and implementation support to project teams developing combination drug delivery devices for parenteral pharmaceutical therapeutics. · The candidate has technical expertise in the development and co ...
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QAPEL MEDICAL INC Fremont, United StatesJob Description · Job DescriptionAbout Q'Apel: · At Q'Apel, we are passionate about revolutionizing neurovascular access. We design novel access device technologies for vascular interventions and unmet clinical needs. In the precious seconds that surround a stroke emergency, clin ...
Quality Engineer Medical Devices - Fremont, United States - Q'Apel Medical, Inc.
Description
About Q'ApelAt Q'Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we're a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Because in the precious seconds that surround a stroke emergency, clinicians need technology that delivers. That's where Q'Apel comes in.
Successful Q'Apel team members step up to the plate and work together to achieve our goals every single day. Our startup philosophy requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.
Job Description Summary
The Quality Engineer position is a hands-on key position with primary responsibility for all areas of Quality Engineering support of Q'Apel's commercial products distributed in domestic and international markets.
This position also supports compliance with the US Quality Systems Regulations, ISO 13485, and the Medical Device Regulation (2017/745) including Q'Apel's quality systems as defined in the company's Quality Manual.
Collects, analyzes, and presents quality metrics of overall fitness and effectiveness of Quality Systems to management as well as key metrics development, analysis, and report out to management.
Position Responsibilities And AuthoritiesQuality Operations
Responsible for all elements of Quality Engineering activities in support of Q'Apel's commercial products distributed in domestic and international markets including the manufacturing, sterilization, inspection, and testing of products.
Support Nonconformance Control and CAPA activities. Assure NCMRs and CAPAs are identified and addressed in a timely manner according to procedure requirements.
Support review of sterilization load documentation and assure compliance with validation requirements. Review lot history records for final product release per established procedure.
Support supplier management implementation and maintenance activities.
Assure suppliers are qualified based upon the risk level assigned and assure supplier monitoring activities are performed in a timely manner.
Support equipment management implementation and monitoring activities (i.e., calibration, preventive maintenance, inspection, installation/ operation/ performance qualifications).Assure on-going monitoring is performed according to procedure requirements and that any issues or nonconformances are addressed in a timely manner.
Assure management is notified and made aware of any concerns involving compliance and/ or product quality.Quality Systems
Champion a strong Quality culture at Q'Apel which includes creating and/ or enhancing systems to be highly effective and efficient and allow high compliance at all stages of the company growth and development.
Maintain current knowledge of the quality system procedures and requirements, including domestic and international regulatory standards and regulations, and ensure compliance is adhered to and training documented.
Assure audit readiness at all times. Support compliance audits from regulatory agencies, internal auditors, and suppliers.Assure training remains up to date.
Coordinate and/ or provide training to company personnel for quality system procedures, annual Quality System Regulation/ ISO 13485/ MDR and other training as required.
Support complaint handling and adverse event reporting activities including returned product investigations. Report findings within the complaint handling processes and in accordance with procedure requirements.Support CAPA activities including root cause analysis, correction, corrective/preventive action plan and verification of effectiveness of implemented actions for an effective CAPA system.
Generate the Quality Review Report, a periodic report of quality system data from key support systems, and communicate results to management via Quality reporting including any concerns involving compliance and/ or product quality.
Safety:
Performs job functions in a safe and effective manner.
Qualification Requirements
Education:
Bachelor's degree in sciences, Engineering or related discipline or equivalent experience in the medical device industry.
Experience & Skills
Experience and knowledge of FDA's Quality System Regulations, ISO 13485, Medical Device Regulations (2017/745) and ISO 14971 Risk Management. Experience with Class III products is preferred.
4+ years Quality Engineering experience in the Medical Device industry with experience in catheter manufacturing, sterilization, and biocompatibility testing. Experience in a start-up environment is preferred.
Strong ability to work effectively with all functions and at all levels both internal and external. Execution minded and biased to achieve goals and objectives in a timely basis.
Strong analytical, problem-solving, and technical writing skills including the ability to independently author protocols and test reports. Ability to solve complex problems, including root cause identification, and implement efficient solutions or processes. Experience with process validations required for FDA and ISO compliance.
Effective communication across all levels of the organization. Strong verbal and written communication skills.
Works well under pressure, organized and self-motivated, independent contributor and strategic thinker and planner. Computer literacy and proficiency in Microsoft Office Suite is required.
May be required to travel.
Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications.
In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly.
After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary.
The base salary range for this full-time position is between $100,000 to $130,000 + equity + benefits.PI
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Quality Engineer Medical Devices professionals in Fremont
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Devin Gray
Full Stack Developer | Web & Mobile