31 applicantsPosted by Agency
Kaygen, Inc. · 3 days ago
Engr 1, Quality
Durham, NC
Full-time
Onsite
Mid, Senior Level
$45/hr - $50/hr
5+ years exp
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Responsibilities
Drives supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities
Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions
Works with suppliers to establish and maintain robust/rigorous measurement methodologies
Partners with suppliers to establish and maintain controlled manufacturing processes
Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.
Performs root cause analysis and corrective actions for supplier quality issues (SCARs)
Performs supplier validation activities using Advanced Product Quality Planning (APQP)
Performs supplier Production Part Approval Process (PPAP) activities
Supports the reporting of supplier quality trends, performance, and other information to leadership
Travel up to 25% may be required
Support and subsequently implements assigned Quality Plans
Supports and if needed owns Corrective Action and Preventive Action (CAPA) projects and implements relative action items
Performs techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)
Partners with suppliers to establish and maintain controlled manufacturing processes
Other duties and responsibilities as assigned
Supports audit, Internal and External
Partners with suppliers to establish and maintain controlled on Supplier imposed changes
Qualification
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Required
Bachelor's degree in an engineering discipline is required
A minimum of 5 year’s total experience in a Quality or Supplier Quality engineering role is required. A minimum or 3 years in Supplier Quality role desired
Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required
Lead Auditor certification is required
CAPA experience- Candidate must have worked and performed root cause analysis
Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting
Demonstrated knowledge of the Quality Engineering body of knowledge is required
Good communication and strong writing skills are required
Candidate must be able to work autonomously and independently
Demonstrated knowledge of DMAIC\Six Sigma and problem-solving methodologies is a required
Preferred
Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus
ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1
Company
Kaygen, Inc.
Kaygen, an award-winning technology consulting and talent firm, assists organizations to achieve digital transformation.
51-200 employees
H1B Sponsorship
Kaygen, Inc. 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
2023 (2)
2022 (2)
2021 (8)
2020 (16)
Funding
Current Stage
Growth StageLeadership Team
Anshul Chaturvedi
Founder & CEO
Rashmi Chaturvedi
Co-Founder & President
Company data provided by crunchbase
