Urgent! Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance) Job Opening In Minneapolis – Now Hiring Arkhya Tech Inc
<p><b>Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance)</b></p> <p><b>Location - </b><b>Minneapolis (Arden Hills and Maple Grove)</b></p> <p><b>Job Type: Contract </b></p> <p><i>Seeking Supplier Quality Engineers with 3+ years' experience in medical devices or regulated industries.
Role involves supplier audits, CAPA/SCAR, process validation, sustaining engineering, and new product development support.
Engineering degree required.</i></p> <p><b>About the role:</b></p> <p> </p> <p> The Supplier Quality Engineer II will demonstrate a primary commitment to patient safety and collaborate with cross-functional internal/external resources to continually improve our supplier's manufacturing processes.
In this role, you will support SFMD products within the Relievant acquisition in the Neuromodulation division with a primary focus on Single-Use Devices and Capital Equipment accessories.</p> <p> </p> <p><b>Your responsibilities include:</b></p> <p>Sustaining Engineering:</p> <ul> <li>Evaluates and communicates quality issues to suppliers and applies sound, systematic problem-solving methodologies in identifying, prioritizing, and resolving quality issues.
Reviews and approves supplier corrective action plans and verification of effectiveness documentation.</li> <li>Proactively assesses supplier capabilities through direct on-site visits and technical discussions.
Coordinates the evaluation of proposed changes at suppliers.</li> <li>Plans and leads supplier audits to assess compliance with regulatory standards and Boston Scientific requirements, including audit scheduling investigation, and evaluation of audit observation and findings, reporting, follow-up, and confirmation of follow-up actions.</li> <li>Manages sustaining quality issues, process change impacts, and design change implementations for suppliers within the Relievant Quality system, the hybridized BSC-Relievant Quality System, and in the BSC Quality System after products are successfully integrated.</li> <li>Investigates and solves non-conformances due to incoming inspection at BSC Distribution Centers.</li> <li>Supports Design Quality Assurance with Field Action and Product Inquiry Reports by performing investigations on supplier-related or supplier-caused quality issues.</li> <li>Investigates complaints and manages NCEPs at OEM suppliers and CM suppliers where the issue is manufacturing-related.</li> <li>Supports Supplier Change Impact Assessments for process changes at suppliers.</li> <li>Supports and performs Finished Good Documentation changes in support of ongoing design changes or labeling updates.</li> <li>Supports projects and contributes to consistently hitting project milestones.
Collaborates on developing crisp and clear project plans and strong contingency plans as part of project planning process.</li> </ul> <p>New Product Development:</p> <ul> <li>Execute SFMD Plan deliverables for integration of acquired company's suppliers and products into BSC's Quality System.</li> <li>Support the execution of SFMD quality deliverables and collaborate with cross-functional new product development teams to onboard finished medical device suppliers.</li> <li>Generate and review quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.</li> <li>Quality System Champion:</li> <li>Collaborates with corporate and regional supplier quality organizations on policy, procedure, and guideline development.
Includes generation, review, and implementation of these documents.</li> <li>Identifies and advises management on potential improvements to quality systems and processes in the company.</li> <li>Champions 100% compliance to company policies and SOP's.</li> </ul> <p><br /> <b>Required Qualifications:</b></p> <ul> <li>BS degree in engineering or technical field with minimum of 2 years of relevant experience.</li> <li>Experience in medical device, automotive, aeronautical, semiconductor, or other regulated industry.</li> <li>Project management: ability to influence cross functional global teams spanning Quality, Operations, R&D, and Sourcing.</li> <li>Experience in process validation, design controls, risk management, CAPA, SCAR.</li> <li>Organized and self-driven.</li> <li>Articulate communicator; adept at packaging and appropriately scaling information to the intended audience.</li> <li>Ability to rapidly learn and use new software applications (e.g., PLM, ERP).</li> <li>Domestic and international travel up to 25%.
</li> </ul> <p><b>Preferred Qualifications:</b></p> <ul> <li>3+ years of medical device engineering experience preferred.</li> <li>Medical Device Industry experience</li> <li>Problem Solving and Project Management experience</li> <li>Leadership experience on a materials or service commodity team.</li> <li>Lead auditor of quality systems experience (ISO 13485 or similar).</li> <li>ASQ certification (CQE, CBA, SSGB, SSBB) desired.</li> </ul> <p> </p>
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Unlock Your Medical Device Potential: Insight & Career Growth Guide
Real-time Medical Device Jobs Trends in Minneapolis, United States (Graphical Representation)
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Great news! Arkhya Tech Inc is currently hiring and seeking a Medical Device QA Engineer (Supplier Quality | Manufacturing | Compliance) to join their team. Feel free to download the job details.
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