Software-Controlled Product Evaluator
vor 4 Wochen
Position Overview:
SciPro is looking for a meticulous and knowledgeable Product Specialist who specializes in the assessment of products that utilize software or are influenced by it, along with those manufactured through metal and plastic fabrication methods. The ideal candidate will play a crucial role in reviewing and auditing these products to guarantee they meet regulatory standards and the company's quality benchmarks.
Primary Duties:
- Perform thorough evaluations of products that integrate software, emphasizing their capacity to manage, oversee, or affect the functionality of active or implantable devices.
- Assess the production methods for items crafted from metal and plastic, ensuring compliance with industry regulations and internal protocols.
- Design and execute audit strategies that mitigate potential risks and compliance challenges associated with software-integrated and processed products.
- Work in partnership with diverse teams, including engineering, manufacturing, and quality control, to pinpoint areas for enhancement and ensure that audit results are acted upon.
- Compile comprehensive audit documentation that details findings, necessary corrective measures, and suggestions for process optimization.
- Remain informed about regulatory guidelines and industry best practices concerning software-integrated products and manufacturing techniques.
- Offer training and support to internal teams on compliance and quality expectations related to software integration and material processing.
- Assist in external regulatory evaluations by preparing necessary documentation and representing the organization in discussions regarding product compliance.
Required Qualifications:
- Bachelor's or Master's degree in Engineering, Quality Assurance, or a related discipline.
- Demonstrated experience in product evaluation, quality assurance, or regulatory compliance.
- In-depth knowledge of software-integrated products, including embedded systems and control software.
- Familiarity with metal and plastic manufacturing processes and methodologies.
- Exceptional analytical abilities and attention to detail.
- Strong communication and report-writing capabilities.
- Ability to collaborate effectively with cross-functional teams.
- Understanding of pertinent regulatory standards (e.g., ISO, FDA) and quality management frameworks.
- Certifications in auditing (e.g., CQA, CQE) are advantageous.
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