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Supplier Quality Engineer II
1 month ago
Primary Talent Partners has a 12 month contract opening for a Supplier Quality Engineer to join a multinational medical device company for an onsite position in North Haven, CT.
Pay:
$45.00/hr - $55.00/hr
Contract:
W-2, 12 months, extensions likely, conversion possible - cannot provide sponsorship or support C2C at this time.
Responsibilities
Ensures that suppliers deliver quality parts, materials, and services.
Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Required Qualifications:
Bachelor’s Degree in Engineering/Scientific/Electronic or technical field
4+ years of relevant experience.
Strong knowledge of change control processes.
Experience leading, supporting, reviewing, and approving supplier change requests, validation, MSA, SCAPA, TMV, PPAP, Risk Assessments, etc.
Experience working with new and existing CMs/Suppliers to develop, implement, and maintain technical quality assurance systems and activities, including SPC, Quality Plans, Control Plans, and FMEAs.
Familiarity with the medical industry requirements such as ISO 13485.
Preferred Qualifications:
Project Management background - experience supporting, coordinating, and/or leading projects.
Remediation experience (DHF, Regulatory compliance, e.g., EU MDR, UKCA).
Experience in the development of new or existing medical devices.
Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.
If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com.
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