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Quality Assurance Specialist I

$30 - $36 per hour

BEPC Inc. - Business Excellence Professional Consulting

BEPC is actively looking for Quality Assurance Specialist I, in Indianapolis, IN area! W2 Contract – 12 months with possible extensions! Benefits include medical, dental, vision, and life insurance Pay Rate: $30.00 - $36.00/hour - Determined based on experience (Paid Weekly) Work Model: Hybrid role - 3 days onsite, 2 days offsite Note : This is a W2 only role — C2C, C2H will not be considered Summary of the Role: BEPC is seeking a highly motivated Supplier Quality Engineer to join our client’s site in Indianapolis, IN. This role will support the ETE IVDR/MDR product verification process for distributed products, including determining product requirements and controls, completing supplier evaluation and approval activities, managing supplier quality processes, monitoring supplier performance, coordinating supplier audits, and ensuring timely resolution of quality issues while collaborating with global cross-functional teams. Summary of Duties and Responsibilities: Manage the ETE IVDR/MDR product verification process for distributed products. Determine product requirements and controls. Complete objective evidence of supplier evaluation and approval. Manage Supplier Corrective Action Requests (SCARs) and ensure timely completion. Address supplier gaps by tracking robust corrective action plans. Complete supplier onboarding activities. Plan and follow up on supplier audits. Ensure supplier actions adequately resolve quality issues and are completed promptly. Identify and escalate issues as they arise and provide appropriate solutions. Qualifications: Education: Bachelor’s or Master’s degree in Life Science, Data Science, or a related field, or equivalent experience. Two or more years of experience in Quality or a related function. Professional experience in a similar role within the medical device sector. Knowledge of deviation and resolution management. Expertise in quality systems, standards, and regulations, specifically production and/or supplier development processes and standards, including ISO 13485 and ISO 27001. Strong analytical skills with a focus on essential facts. Cultural awareness and experience working with global internal and external partners and suppliers. Leadership mindset with the ability to lead others within an agile organization. Willingness and flexibility to collaborate across global teams in different time zones, including early working hours to support collaboration with colleagues in the European Union. Decisive with the ability to initiate and complete daily activities and proactively find solutions independently with limited guidance. About BEPC BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth. #J-18808-Ljbffr BEPC Inc. - Business Excellence Professional Consulting

Vacancy posted 3 days ago
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