RQM+ is the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.
We are currently looking for Manufacturing Engineers with Material Management
experience including the following: Non-conforming material disposition management of, manufacturing engineer and quality engineer, incoming inspection of material, process of incoming inspection, review the testing documentation accompanying that material, receipt of materials in manufacturing setting, segregating materials, movement and reporting of material in that process, communication back to suppliers (SCARS), experienced manufacturing engineers
Responsibilities:
- Management of Non-Conforming material disposition
- Collaborate across functions and sites, leveraging quality, regulatory and manufacturing expertise to troubleshoot problems, interpret data and determine next steps based on risk-based approach.
- Manage problem requests (nonconformances), complaint records, and corrective and preventive actions (CAPAs)
- Support in global change control activities for documents and manufacturing processes and support harmonization activities if required (the QMS roles for this project are global).
- Assist with regulatory, customer and internal audits
- Provide guidance and direction to ensure ISO/Quality system compliance with expertise in 21 CFR part 820, ISO 13485:2016, MDSAP and EU MDR
- Manage maintenance, completeness and accuracy of Quality records
- Create and review quality processes and procedures
- Collect, analyze, trend and report out on quality metrics
- Drive a culture of continuous improvement
- Supports complex, cross-functional quality issues in a variety of subject matter areas (e.g. biology, electrical, mechanical, chemistry and software) and drives resolution and proactive solutions to customer complaints (functional defects with components or performance related failures), backorder issues, and material disposition.
- Proactively investigating, identifying, and implementing best-in-class Quality Engineering practices.
Requirements:
- BS in Mechanical Engineering, Biomedical Engineering, Process Engineering, Analytical Chemistry, or related technical discipline, preferred.
- 5+ years of experience in regulated Medical Device Quality Systems environment
- Excellent communication, colllaboration and interpersonal skills with the ability to facilitate team interactions, partner with and influence key stakeholders.
- Work with diverse teams, guide teams through decision making, facilitate agreement, build collaborative relationships and focus on customer needs.
- Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency.
- Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts.
- Expert knowledge of quality standards (e.g., 21 CFR Part 820, ISO 13485, MDSAP, excipient manufacturing regulations) and Quality Management System design and oversight from a Medical Device perspective.
- Compliance with regulated quality management system standards
- Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis
- Global Systems e.g. TrackWise, AGILE, E1, LIMS
- Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
- Strong understanding of Medical Device QSR and ISO 13485.
- Previous experience participating in the development and results analysis of validation plans (IQ/OQ/PQ) and test protocols to qualify and validate existing and new product designs and processes.
Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today! We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us. We require willingness to work a flexible schedule and travel at least 25% of the time Apply for this job
