Quality Assurance Technician
Quality Assurance Technician
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Job Description
About Us
Spellman High Voltage Electronics Corporation a family owned business for over 75 years takes pride in powering progress in health security and quality of life. We are key partners with the worlds leading medical devices semiconductor scientific analytics and industrial systems manufacturers. When they want to push the limits of whats possible with high voltage applications they turn to us to make it happen.
While Spellman is not a household name our products are used to make and often power many of the most advanced technologies that make modern life possible. With design and manufacturing sites in North America Europe and Asia we have become the preferred provider of high voltage power solutions for OEMs pushing the boundaries of technology around the world by designing and producing the products they need to power progress.
Description of function and responsibility (scope)
Quality assurance combines different approaches and measures to ensure that defined quality requirements are met in accordance with the quality policy. It is not an instrument for quality improvement.
Owner for the process SOP 804 Control of nonconforming products (NCP) in compliance with all specified applicable procedures both compliance with all necessary processes and full communication with suppliers internally and externally (MA Quality Assurance)
Owner of the DHR process with regard to production (Device History Record product creation file)
MA document control area DHR
DHR documentation according to specifications and table of contents check for formal correctness and release for delivery
Check and digital recording of all serial numbers in the SN program as well as the generator structure (PDF version)
Closure of the DHR including the forwarding or filing of the documents in the archive. Furthermore maintenance of the DHRs in the event of changes in the course of replacement material and/or complaints
Management monitoring release and communication of order/ and customerspecific documents internal specifications material Bookings in ERP system and physical handling (securing access control etc.))
Development and execution of statistical recording and evaluation as well as triggering CAPAs for nonconformities and/or potential nonconformities
Responsibility in the complaint process
Initial documentation upon receipt of complaint
Documentary preparation including research and proper material provision for further processing of the complaint
Completion of documentation up to the filing of customer folders as well as communication data record and statistical evaluation.
Statistical analysis and communication (German/English) of the results of qualityrelevant key figures in particular with regard to complaints NCP and DHR
Implementation of and compliance with qualitative requirements for products and processes
Carrying out product and process audits.
Initial contact person for qualityrelated questions from customers
Evaluation of quality indicators and initiation of appropriate corrective actions
Participation in risk assessments (FMEA) as well as validations and approvals of manufacturing processes (change management)
Management and evaluation of quality indicators
Approval of process validations
Tracking and leading the implementation of corrective actions
Processing and tracking of complaints in particular of supplier quality
Ensuring proper product release and its documentation
Qualification profile
Completed commercial or technical training combined with several years of professional experience in production and/or quality assurance
Experience working withing the medical technology sector experience would be advantageous
Bachelors degree in electrical manufacturing or mechanical engineering or equivalent.
Training in Six Sigma Green Belt or Black Belt
Necessary skills and competencies
Knowledge and experience in the quality management system medical device industry and/or similar
ERP system complaint management MSOffice
Complaint management TV Nord 08.05.09.05.2019
Min. 3 years of experience in working with relevant quality management systems ISO 9001 ISO 14385 TS 16949 or similar systems
Indepth experience with problem solving methodologies 8D and/or A4 methodology DOE or similar methods
Experience with statistic process control (SPC) and its analytical evaluations Pareto control charts histogram etc.
Experience in handling electronic parts and components
Confident handling of MS Office
We at Spellman High Voltage Electronics Corporation believe that each individual is entitled to equal employment opportunities without regard to race color creed gender sexual orientation gender identity marital status national origin age veteran status or disability. The right of equal employment opportunity extends to recruiting hiring selection transfer promotion training and all other conditions of employment. To request accommodation related to disabilities please email us at or call 1 (631)
Note to Recruiters and Placement Agencies: Spellman High Voltage Electronics does not accept unsolicited agency resumes. Please do not forward unsolicited agency resumes to our website or to any Spellman High Voltage Electronics employee. Spellman High Voltage Electronics will not pay fees to any third party agency or firm and will not be responsible for any agency fees associated with unsolicited resumes. Unsolicited resumes received will be considered property of Spellman High Voltage Electronics and will be processed accordingly.
Required Experience:
IC
Employment Type
Full-Time
