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Job Description:

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As a Quality Engineer supporting Manufacturing you are responsible for achieving timely and cost-effective manufacturing of high-quality medical devices. The Quality Engineer is accountable for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Key duties include collaborating with internal and external stakeholders to achieve company objectives, contributing to technical root cause investigations, executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

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Responsibilities include but are not limited to:

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• Contributes to investigations into production and customer-facing quality issues of medium complexity to identify root cause, implement corrective and preventative actions, and monitor effectiveness. May execute tasks to support higher complexity investigations.

• Demonstrates conceptual understanding and application of role-specific technical and Quality skills.

• Develops cross-functional relationships to successfully influence behavior within a team or project.

• Monitors global product performance using a data-driven statistical analysis and risk-based approaches.

• Effectively communicates (written and verbal) technical problems and solutions within small teams and to direct manager.

• Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.

• Develops and improves manufacturing processes by studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors.

• Improves manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.

• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies pertaining to medical devices. Supports internal/external audits.

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Minimum Required Experience/Education:

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• Bachelor's Degree or Equivalent years of directly related experience (or high school+8yrs; Assoc.+4yrs).

• The ability to fluently read, write, understand and communicate in English.

• 0-1 years of relevant industry experience.

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Preferred Qualifications/Skills/Experience:

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• Preferred 1-3 years experience in Quality/Manufacturing/Operations/Engineering in Medical Device or Healthcare.

• Excellent verbal/written communication skills.

• Experience with MS Office, Excel, PowerPoint, Visio, MS Teams, and Sharepoint.

• Experience in leadership, project management, effective decision-making capabilities, strong analytical, problem solving and negotiation skills.

• Exposure to hands-on troubleshooting of complex electromechanical/optical machines/consoles.

• Experience working in MRP systems (i.e. SAP).

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About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

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ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

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