Senior Quality Engineer @ Redbock - an NES Fircroft company | Jobright.ai
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Redbock - an NES Fircroft company · 4 days ago

Senior Quality Engineer

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BiotechnologyConsulting
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H1B Sponsorship
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Growth Opportunities

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Responsibilities

Lead PPAP qualifications with the CMs.
Collaborate with CMs to develop robust SCAPAs.
Support the Quality team to develop and improve an effective Supplier Quality process.
Work with CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities.
Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their quality plans.
Build and own the strategy for managing the CMs/Suppliers.
Communicate with the business Quality lead on CM initiatives, updates, and issues.
Partner with Supplier Quality Managers to build a strategy for managing the CMs in all regions.
Ensure CM compliance with business Quality Systems and internal procedures.
Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions.
Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions.
Develop a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies.
Ensure proper approval and documentation practices are followed for any process, material or tooling change at CMs.
Define and manage the process for growing effective partnerships with preferred CMs.
Lead by Example in setting a continuous-improvement driven mentality and solid quality culture.
Maintain compliance to Key Performance Indicators and operational standards.
Manage and report on CMs/Suppliers audit program in line with ISO and/or FDA regulations.
Translate engineering, manufacturing, and quality requirements for CM products.
Perform deviation investigations into quality issues arising from CM activities.
Manage qualifications of changes and co-ordinates associated change control activities.
Evaluate CMs using the appropriate CM performance management processes and develop reports on CM quality performance.
Ensure effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained.
Participate in annual supplier forums and business reviews.

Qualification

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Supplier QualityQuality EngineeringReliability EngineeringSupplier ChangesPPAP ExpertiseRisk ManagementFMEAsMSAsSPCQuality PlansControl PlansCMs/Suppliers Collaboration

Required

Bachelor’s Degree in an Engineering/Scientific/Electronic or technical field
Minimum 5 years experience in a Supplier Quality, Quality Engineering or Reliability Engineering function
Supplier changes (PPAP) expertise
Development/review of Risk management documents (FMEAs)
Work with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including MSAs, SPC, Quality Plans, Control Plans, and FMEAs

Company

Redbock - an NES Fircroft company

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Redbock is a consultancy that delivers customized resourcing solutions to pharmaceutical, biotechnology, medical device and diagnostics companies.

H1B Sponsorship

Redbock - an NES Fircroft company 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 (7)
2020 (10)

Funding

Current Stage
Growth Stage
Total Funding
unknown
2018-06-20Acquired· by NES Global Talent
Company data provided by crunchbase
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