Quality Engineer - Schoolcraft, United States - Amy Cell Talent

Description

Job Description

A rapidly evolving medical device company seeks an ambitious Quality Engineer to play a critical role in executing the company's strategy by contributing to both products and processes that support our customers.

About Us

C2Dx is a medical device company that acquires and invests in underserved products to propel their impact worldwide. Founded in early 2019 by industry experts, C2Dx is committed to providing leading medical products and superior customer service while continually evolving to ensure that healthcare providers have the devices and technology they need. To learn about our exciting products, see here.

About the Role

The Quality Engineer will provide Quality System improvements with significant time spent troubleshooting, diagnosing failure modes, and recommending solutions to improve customer loyalty. You will work alongside cross-functional teams and support our products, services, and Quality System.

Responsibilities:

• Execute Quality and Regulatory strategies to enhance profitability
• Provide development support and maintenance of the quality management system processes in accordance with relevant regulatory requirements
• Research, organize, and draft business process maps and knowledge layer documents
• Help process owners and SMEs navigate the Document Management Process
• Manage the preparation, review, and submission of pre-market submissions, technical files, and design dossiers, including establishing necessary written procedures, such as for submission review, applications, CE marking and clearance. (US and OUS compliance)
• Serve as a Regulatory representative on new product development and sustaining engineering project teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions
• Review and approve product and manufacturing changes for compliance with applicable regulations and developing and implementing departmental policies
• Drive a culture of safety and efficacy through Quality tools such as 6S
• Support supplier Audit, Internal Audit, CAPA, Nonconforming Product Procedure, Customer Feedback and Complaints, Vigilance, and duties as required by Management
• Contribute towards process improvements to the C2Dx Quality Management System

About You:

• Experience in ensuring compliance and assisting with adherence to the Quality Management system in a medical device or related industry
• Prior experience in regulated environment highly desired
• Experience supporting Quality audits required
• Experience with Quality Risk Management required
• Experience in the development and refinement of Design and Process FMEA (Failure Mode and Effects Analysis)
• Experience managing projects and change management is highly preferred
• Microsoft Office Suite, specifically Excel proficiency is required
• A degree in engineering or related field or a combination of education and experience necessary to perform the job

Why work for us?

• Unique opportunity to work on the business and engineering sides of the organization
• You will learn about manufacturing of diverse product lines to propel your career growth
• Opportunity to own an entire project and participate in new product development for a new product
• Opportunities for upward and internal mobility and professional development
• Access to leadership with a wealth of experience in a flat organization
• A culture with a high level of transparency where your voice is heard and respected
• We thrive on identifying untapped potential of all team members to cross train and help them reach their professional and personal goals
• Competitive compensation and benefits package

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