What are the responsibilities and job description for the Software Quality Engineer IV position at Medical Engineering Consultants (MEC)?
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Hybrid position - 3 days in Marl Local candidates preferred and will go to top of list *Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. The Client is unable to consider candidates who require sponsorship. JOB TITLE: Global Quality Mgt. Systems Engr and Project Management Position Summary: Candidate will provide dedicated support for strategic Global Quality Systems initiatives by assessing designing implementing and continuously improving enterprise Quality Management System QMS processes governing Supplier Controls and Sourced Device Material Controls. This role supports implementation of evolving global regulatory requirements for Sourced Finished Medical Devices SFMD including embedded and associated software Software as a Medical Device SaMD cybersecurity Artificial Intelligence AI digital health medical device components and other outsourced products and services. Candidate will serve as the dedicated lead for supplier-related QMS process enhancements across multiple enterprise initiatives. Partnering closely with the Global Process Stewards for Supplier Controls and Sourced Device Material Controls this role will support the evaluation and prioritization of strategic initiatives translate business and regulatory requirements into process enhancements and lead implementation to ensure consistent sustainable execution of Supplier Controls and Sourced Device Material Controls that support emerging digital technologies and evolving global regulatory expectations. Working across Global Supplier Quality Global Quality Systems Global Sourcing Regulatory Affairs Legal Cybersecurity Software Engineering Digital Health Information Technology and Research Development the Technical Process Lead will provide technical leadership process leadership and project coordination to drive supplier quality system enhancements from concept through implementation. The successful candidate will proactively identify process gaps facilitate cross-functional alignment drive technical and process decisions manage implementation activities and ensure project milestones and deliverables are achieved while delivering sustainable QMS improvements. Key Responsibilities: Lead the assessment design implementation and continuous improvement of Supplier Controls and Sourced Device Material Controls processes supporting technology suppliers Sourced Finished Medical Devices SFMD medical device component suppliers OEMs Contract Manufacturers and other outsourced providers. Partner with the Global Process Stewards to provide technical and process leadership for strategic Quality Management System initiatives. Collaborate to assess business and regulatory needs prioritize process enhancements establish implementation roadmaps and drive execution of Supplier Controls and Sourced Device Material Controls improvements across the enterprise. Drive cross-functional implementation by facilitating workshops coordinating stakeholders managing action items resolving issues and ensuring supplier quality initiatives progress according to project objectives and timelines. Assess and enhance supplier assessment and supplied device/material qualification processes supplier lifecycle management supplier change management supplier remediation supplier risk management and the Supplier Change Impact Assessment SCIA process ensuring supplier controls appropriately address software cybersecurity AI-enabled technologies cloud services digital health and evolving regulatory expectations. Develop revise and implement QMS procedures work instructions templates forms quality records and supporting documentation to establish sustainable inspection-ready supplier quality processes. Enhance responsibility allocation matrices e.g. RACI/QPTP and quality ownership models for Contract Manufacturers CM Contract Design Manufacturers CDM Original Equipment Manufacturers OEM OEM models and technology suppliers. Define and document responsibilities associated with software design and development software design transfer AI development and lifecycle activities cybersecurity software lifecycle activities risk management and risk transfer supplier oversight post-market cybersecurity and change management. Collaborate with Global Sourcing Legal Regulatory Affairs and Quality stakeholders to update quality agreements supplier agreements and QMS-related contractual requirements to reflect evolving quality regulatory software cybersecurity AI design control supplier oversight and post-market responsibilities. Support supplier remediation activities internal audits regulatory inspections and Quality System initiatives by implementing sustainable process improvements and maintaining inspection-ready documentation. Monitor emerging regulations standards and industry guidance and translate new requirements into practical risk-based enhancements to Supplier Controls and Sourced Device Material Controls processes. ************************************************************** Required Qualifications Bachelor's degree in Engineering Quality Computer Science Cybersecurity Software Engineering Information Systems Life Sciences or a related technical discipline. 5 or more years of experience in Quality Systems Supplier Quality Supplier Controls Sourced Device Material Controls Regulatory Compliance or related quality functions within a regulated industry. Demonstrated experience assessing designing implementing and improving QMS processes including supplier assessments supplier controls supplier documentation quality agreements responsibility allocation matrices and outsourced process controls. Experience supporting software suppliers cloud service providers technology suppliers SFMD suppliers component suppliers OEMs Contract Manufacturers or other outsourced providers. Strong understanding of supplier assessments supplier lifecycle management supplier responsibility models outsourced process controls risk-based quality principles and QMS documentation. Working knowledge of FDA 21 CFR Part 820/Quality Management System Regulation QMSR ISO 13485:2016 including supplier purchasing and outsourced process controls ISO 14971 FDA inspection and MDSAP expectations 21 CFR Part 11 FDA Computer Software Assurance CSA and applicable FDA post-market requirements. Familiarity with EU MDR/IVDR IEC 62304 IEC 82304-1 IEC 81001-5-1 FDA software and cybersecurity guidance IMDRF SaMD guidance AI/ML regulatory and risk management frameworks and quality system expectations for emerging digital technologies. Demonstrated ability to independently lead cross-functional initiatives influence stakeholders facilitate decision-making manage multiple priorities and deliver complex process improvements in a global matrixed organization. Excellent communication facilitation organizational and project management skills. ===================================================================== Preferred/desired Experience: Experience in the medical device or other regulated healthcare industry. Experience implementing enterprise Quality Management System improvements or large-scale compliance initiatives. Experience supporting Supplier Controls and Sourced Device Material Controls for software cybersecurity AI-enabled technologies digital health cloud services SaMD SFMDs medical device components OEMs Contract Manufacturers or other outsourced providers.
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Hybrid position - 3 days in Marl Local candidates preferred and will go to top of list *Applicants must be authorized to work in the U.S. without visa sponsorship now or in the future. The Client is unable to consider candidates who require sponsorship. JOB TITLE: Global Quality Mgt. Systems Engr and Project Management Position Summary: Candidate will provide dedicated support for strategic Global Quality Systems initiatives by assessing designing implementing and continuously improving enterprise Quality Management System QMS processes governing Supplier Controls and Sourced Device Material Controls. This role supports implementation of evolving global regulatory requirements for Sourced Finished Medical Devices SFMD including embedded and associated software Software as a Medical Device SaMD cybersecurity Artificial Intelligence AI digital health medical device components and other outsourced products and services. Candidate will serve as the dedicated lead for supplier-related QMS process enhancements across multiple enterprise initiatives. Partnering closely with the Global Process Stewards for Supplier Controls and Sourced Device Material Controls this role will support the evaluation and prioritization of strategic initiatives translate business and regulatory requirements into process enhancements and lead implementation to ensure consistent sustainable execution of Supplier Controls and Sourced Device Material Controls that support emerging digital technologies and evolving global regulatory expectations. Working across Global Supplier Quality Global Quality Systems Global Sourcing Regulatory Affairs Legal Cybersecurity Software Engineering Digital Health Information Technology and Research Development the Technical Process Lead will provide technical leadership process leadership and project coordination to drive supplier quality system enhancements from concept through implementation. The successful candidate will proactively identify process gaps facilitate cross-functional alignment drive technical and process decisions manage implementation activities and ensure project milestones and deliverables are achieved while delivering sustainable QMS improvements. Key Responsibilities: Lead the assessment design implementation and continuous improvement of Supplier Controls and Sourced Device Material Controls processes supporting technology suppliers Sourced Finished Medical Devices SFMD medical device component suppliers OEMs Contract Manufacturers and other outsourced providers. Partner with the Global Process Stewards to provide technical and process leadership for strategic Quality Management System initiatives. Collaborate to assess business and regulatory needs prioritize process enhancements establish implementation roadmaps and drive execution of Supplier Controls and Sourced Device Material Controls improvements across the enterprise. Drive cross-functional implementation by facilitating workshops coordinating stakeholders managing action items resolving issues and ensuring supplier quality initiatives progress according to project objectives and timelines. Assess and enhance supplier assessment and supplied device/material qualification processes supplier lifecycle management supplier change management supplier remediation supplier risk management and the Supplier Change Impact Assessment SCIA process ensuring supplier controls appropriately address software cybersecurity AI-enabled technologies cloud services digital health and evolving regulatory expectations. Develop revise and implement QMS procedures work instructions templates forms quality records and supporting documentation to establish sustainable inspection-ready supplier quality processes. Enhance responsibility allocation matrices e.g. RACI/QPTP and quality ownership models for Contract Manufacturers CM Contract Design Manufacturers CDM Original Equipment Manufacturers OEM OEM models and technology suppliers. Define and document responsibilities associated with software design and development software design transfer AI development and lifecycle activities cybersecurity software lifecycle activities risk management and risk transfer supplier oversight post-market cybersecurity and change management. Collaborate with Global Sourcing Legal Regulatory Affairs and Quality stakeholders to update quality agreements supplier agreements and QMS-related contractual requirements to reflect evolving quality regulatory software cybersecurity AI design control supplier oversight and post-market responsibilities. Support supplier remediation activities internal audits regulatory inspections and Quality System initiatives by implementing sustainable process improvements and maintaining inspection-ready documentation. Monitor emerging regulations standards and industry guidance and translate new requirements into practical risk-based enhancements to Supplier Controls and Sourced Device Material Controls processes. ************************************************************** Required Qualifications Bachelor's degree in Engineering Quality Computer Science Cybersecurity Software Engineering Information Systems Life Sciences or a related technical discipline. 5 or more years of experience in Quality Systems Supplier Quality Supplier Controls Sourced Device Material Controls Regulatory Compliance or related quality functions within a regulated industry. Demonstrated experience assessing designing implementing and improving QMS processes including supplier assessments supplier controls supplier documentation quality agreements responsibility allocation matrices and outsourced process controls. Experience supporting software suppliers cloud service providers technology suppliers SFMD suppliers component suppliers OEMs Contract Manufacturers or other outsourced providers. Strong understanding of supplier assessments supplier lifecycle management supplier responsibility models outsourced process controls risk-based quality principles and QMS documentation. Working knowledge of FDA 21 CFR Part 820/Quality Management System Regulation QMSR ISO 13485:2016 including supplier purchasing and outsourced process controls ISO 14971 FDA inspection and MDSAP expectations 21 CFR Part 11 FDA Computer Software Assurance CSA and applicable FDA post-market requirements. Familiarity with EU MDR/IVDR IEC 62304 IEC 82304-1 IEC 81001-5-1 FDA software and cybersecurity guidance IMDRF SaMD guidance AI/ML regulatory and risk management frameworks and quality system expectations for emerging digital technologies. Demonstrated ability to independently lead cross-functional initiatives influence stakeholders facilitate decision-making manage multiple priorities and deliver complex process improvements in a global matrixed organization. Excellent communication facilitation organizational and project management skills. ===================================================================== Preferred/desired Experience: Experience in the medical device or other regulated healthcare industry. Experience implementing enterprise Quality Management System improvements or large-scale compliance initiatives. Experience supporting Supplier Controls and Sourced Device Material Controls for software cybersecurity AI-enabled technologies digital health cloud services SaMD SFMDs medical device components OEMs Contract Manufacturers or other outsourced providers.
MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.