Sr. Supplier Quality Engineer

Onsite (with some flextime 3 days in office and 2 Remote)

Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.

24 month contract with possible conversion to permanent employment if desired.

Qualifications :

• Bachelor's Degree and 5 years experience in Supplier Quality
• Supplier changes (PPAP) expertise
• Risk management documents
• 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

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 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
• 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
• Lead by Example : Setting continuous-improvement driven mentality and solid quality culture for the organization
• Maintain compliance to set Key Performance Indicators for the business
• Maintain the highest level of compliance and operational standards set by the business
• 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 coordinate 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
• Participate in annual supplier forums and business reviews

Job Disclaimer :

Equal Opportunity Employer / Veterans / Disabled

Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan.

Our program provides employees the flexibility to choose the type of coverage that meets their individual needs.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https : / / www.

entegee.com / candidate-privacy-information-statement /

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

Job Type : Contract

Pay : $50.00 - $65.00 per hour

Expected hours : 40 per week

Schedule :

• 8 hour shift
• Day shift
• Monday to Friday

Education :

Bachelor's (Required)

Experience :

• Supplier Quality Engineering : 5 years (Required)
• Supplier Changes (PPAP) : 2 years (Required)
• Risk management : 2 years (Required)
• Medical Device : 1 year (Required)

Work Location : In person

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