Akkodis is seeking a Senior Supplier Quality Engineer for a medical device manufacturer in North Haven, CT.

The Senior Supplier Quality Engineer is responsible to represent the quality engineering function to develop and execute the strategy to organize, direct, and report on all supplier quality-related activities for design and manufactured items. The primary focus will be supplier selection, qualification, manufacturing, and review of technical quality documentation that includes Risk Management Documentation.

Pay/Salary Range: $60.00 hr - 65.00 hr

Hybrid with minimum 3 days a week onsite

12 month contract (could be extended)

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

Qualifications:

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

Medical Device experienced is highly preferred

If you are interested in this Senior Supplier Quality Engineer job North Haven, CT, then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.modis.com/en-us/candidate-privacy/

The Company will consider qualified applicants with arrest and conviction records.