TekniPlex · 5 days ago
Senior Quality Engineer
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IndustrialManufacturing
Insider Connection @TekniPlex
Responsibilities
Act in conjunction with Quality Manager as a technical contact on quality related issues for internal and external customers.
Respond quickly to customer quality issues including performing investigations, applying root cause analysis and problem-solving techniques to address concerns.
Development and implementation of quality system documentation and maintenance.
Responsible for leading validation of new gauging equipment, new process equipment and products.
Assist in audits (internal and external) by third party registrars and / or customers and maintaining the ISO 9001 and ISO 13485 procedures and work instructions.
All other duties as assigned.
Qualification
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Required
Bachelor’s degree in a related engineering field such as mechanical, industrial or chemical is required with 5+ years in a Quality Engineering role.
At least 5+ years validation experience in a manufacturing environment.
Lean Six Sigma is required; certification is a plus.
Experience with ISO 13485
Ability to independently apply analytical skills, complex scientific technical principles and detailed knowledge in solving engineering problems.
Clear understanding and application of DOE, DFMEA and PFMEA methodologies.
Experience with Statistical Process Control methods (control charts, CpK’s, etc.).
Knowledge of Good Manufacturing Practices (GMP’s) encompassing plastics extrusion lines, calculations of speeds, material composition understanding, comprehension of the basic function of fixtures and familiarity with inspecting and checking methods.
Proficient in Gauge R & R metrology. Ability to read and interpret prints and tool designs.
Ability to troubleshoot / solve problems independently or as part of a team.
Excellent verbal and written communication skills. Ability to, internally and externally, discuss and clearly define key technical and process development issues and independently develop course of action / plans.
Minitab or equivalent statistical software is required.
Excellent computer skills including Microsoft applications. Data base experience is a plus.
Must be hands on and willing to work in production environment including off shifts when projects require.
Ability to travel to division and customer locations to support product and process related projects and quality concerns.
Company
TekniPlex
TekniPlex is a globally integrated company that provides innovative solutions through materials science and manufacturing technologies.
H1B Sponsorship
TekniPlex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2022 (1)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2017-10-17Acquired· by Genstar Capital
Recent News
Med-Tech Innovation
2022-12-09
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