31 applicants

Company

Original Job Post

Akkodis · 4 days ago

Senior Supplier Quality Engineer

North Haven, CT

Contract

Onsite

Senior Level

$60/hr - $65/hr

5+ years exp

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IT Services and IT Consulting

H1B Sponsorship

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Hiring Manager

Kitty Polley

Insider Connection @Akkodis

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Responsibilities

Lead PPAP qualifications with the Contract Manufacturers (CMs)

Collaborate with CMs to develop robust SCAPAs

Support the Quality team (member of) to develop and improve an effective Supplier Quality process that supports finished goods product quality globally.

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

Collaborate on New Product Development (NPD) teams to evaluate and understand future CMs and their associated quality and development plans

Build and own the strategy for managing the CMs/Suppliers for the business

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 all relevant internal procedures and policies

Facilitate customer complaints for CM products and ensure adequate investigation and corrective actions are taken by CMs

Manage Supplier Corrective Action Request program to ensure consistency in handling corrective actions by CMs

Develop, communicate, and manage a strategy/plan for addressing finished goods CMs/Suppliers capability deficiencies, etc.

Ensure proper approval and documentation practices are followed for any process, material or tooling change (SCR – Supplier Change Request) at CMs

Define and manage the process for growing effective 'partnerships' with preferred CMs (to drive optimal performance) founded on common interest and which demonstrate trust, loyalty and financial success

Manage and report on CMs/Suppliers audit program in line with ISO and/or FDA 21 CFR part 820 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 for company management, recommend and implement the continuous improvement of CM quality systems

Responsible for ensuring that effective up-to-date CM Quality Assurance documentation, procedures, and specifications are maintained

Qualification

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Medical Device Experience

Required

Bachelor’s Degree and 5 years of Supplier Quality experience Supplier Quality, Quality Engineering or Reliability Engineering function

Medical Device experienced is highly preferred

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Short-Term Disability

Additional Voluntary Benefits

Employee Assistance Program (EAP)

Commuter Benefits

401K Plan

Company

Akkodis

Glassdoor

3.3

Akkodis is a digital engineering company and Smart Industry leader.

10,001+ employees

https://www.akkodis.com

H1B Sponsorship

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2023 (59)