Quality Technician, Senior

General Summary: Perform inspections and tests on incoming material, in process and finished product to ensure that quality standards and process controls are being met throughout the manufacturing process. Generate the appropriate documentation, records, and reports. Support quality, engineering, and manufacturing as needed.

 

Essential Duties and responsibilities:

· Perform Incoming Visual/Dimensional (V&M) inspections, in process (SPC), and Final inspections as required.

· Review and verification of certification documentation, inspection and testing of parts for compliance to drawings and/or specifications, detailed documentation of results, generation of certificate of compliance, and proper maintenance of records.

· Generate various quality and process performance reports.

· Generate NCMR reports and initiate corrective actions as needed.

· Maintain IQA inspection database with required records.

· Generate/maintain database for in process and final inspection information.

· Review defect data and generate Pareto charts for distribution.

· Disposition non-conforming material through the MRB process.

· Administration of the Calibration program

· Reviewing and analyzing product specifications and market requirements pertaining to EMC, Radio, Safety, Energy Efficiency and/or International Compliance.

· Review client’s active (powered) medical devices for regulatory requirement mainly for European and US markets. Utilize knowledge of regulatory requirements applying to processes and products of the client.

· Advising hardware development teams through the development cycle with respect to compliance requirements, testing, labeling on products.
Attending meetings and providing effective input and feedback.
Ensuring accurate communication, status update and reporting across groups.

· Work with minimal supervision to assess compliance to the regulatory requirements, utilizing efficient and effective time management skills. Identifying compliance-related issues and providing innovative cost-effective solutions. Working productively and seamlessly as a member of a skilled team of compliance professionals

· Create reports for clients utilizing analytical skills, technical knowledge and excellent written communication skills. Utilize professional presentation skills while meeting with clients to present findings.

· Administer the document control system for all controlled internal and external documents to comply with ISO requirements.  Administer the document change request system to ensure that the most current revisions are available to the workforce and that the change requests are quickly acted upon



Qualifications:

·  Broad knowledge of engineering and/or Bio-technical applications used in the development of medical devices a plus

·  Strong project management skills

·  Strong mathematical skills.

·  Good understanding of product compliance.

·  Ability to work with ambiguities a must.

·  Ability to use measurement tools (calipers, micrometers, various gauging).

 



Education and /or experience:

· ASEE degree (BSEE preferred)

·  5 years of progressive, professional electrical engineering experience OR

·  An equivalent combination of education and experience

 

Desired:

·  Specific experience in applied design and development of regulated products or Regulatory Affairs field concerning active medical devices

· Experience as a compliance engineer focusing in safety, EMC, Radio, Energy Efficiency, international regulatory certifications or a similar discipline with 3 or more years of high-volume consumer electronics experience

· Experience with ISO and/or FDA compliance issues

 



Language skills:Excellent written and verbal communication skills required to seamlessly work across groups and at all levels



Computer skills:Working knowledge of Micro Soft Office Suite, particularly ExcelExperience with Epicor a plus



Physical demands:

· Ability to climb in overhead structures, to work beneath machines and in close quarters performing analysis and repair work.

· Must be highly safety conscious.

· Exposed to high voltage electricity

·  Ability to lift up to 50 pounds