Senior Project Quality Engineer na invoX Belgium N.V.
invoX Belgium N.V. · Diepenbeek, Bélgica · Hybrid
- Senior
- Escritório em Diepenbeek
The Senior Project Quality Engineer will lead both internal and external project compliance, to enhance product quality and regulatory alignment, within design transfer timelines and compliance frameworks. The role will cover full product lifecycle from development to commercial-scale manufacturing.
They will additionally oversee master validation activities including SKU process validation and control planning for both commercial drug product and medical device manufacturing, and support vendor management, vendor readiness and design transfer activities.
The Senior Project Quality Engineer will manage Project Quality Engineers and work closely with internal stakeholders, technical project leaders (TPL), external vendors, and regulatory bodies to maintain compliance with ISO 13485, EU MDR (2017/745), and US FDA regulations and project timelines.
Key Responsibilities
Design Transfer & Transfer Readiness
- Support end-to-end design transfer activities (internal and external) to ensure product realization meets regulatory and quality standards.
- Oversee external master validation activities in line with design transfer timelines, for commercial drug product Fill&Close and medical device tooling and auto-assembly lines, alerting senior leadership to issues.
- Ensure alignment between vendor validation activities and internal quality standards.
- Oversee validation plans and activities for internal systems, development and bench equipment, supporting resolutions in collaboration with design and engineering teams.
- Lead internal compliance with Design Control, Risk Management, and related Invox Standard Operating Procedures (SOPs).
- Support QA review of Invox Belgium project documents and records as necessary
(including Design Control, Risk Management, Design Review).
- Oversee external master validation activities in line with design transfer timelines, for commercial drug product Fill&Close and medical device tooling and auto-assembly lines, alerting senior leadership to issues.
- Ensure alignment between vendor validation activities and internal quality standards.
- Oversee validation plans and activities for internal systems, development and bench equipment, supporting resolutions in collaboration with design and engineering teams.
- Lead internal compliance with Design Control, Risk Management, and related Invox Standard Operating Procedures (SOPs).
- Support QA review of Invox Belgium project documents and records as necessary
(including Design Control, Risk Management, Design Review).
Vendor Management, Auditing & Oversight
- Support the extension and growth of vendor management and vendor readiness activities to cover full product lifecycle from development to commercial-scale manufacturing.
- Manage the vendor auditing program covering all aspects of Project QA to ensure compliance with ISO 13485, FDA QSR, and MDR 2017/745 and Invox QAAs.
- Lead or support vendor qualification, surveillance, or for cause audits, from agenda to reporting, approval of CAOA plan and tracking to close-out.
- Establish and manage vendor risk assessments and performance monitoring, to ensure continued compliance, reliability, and timeliness in both development and commercial production.
- Implement root cause analysis (RCA) and CAPA frameworks to drive vendor continuous improvement and risk mitigation.
- Lead external compliance with requirements for quality event handling.
- Support QA review of vendor project documents and records as necessary
(including protocols, reports, methods, validation and batch records).
- Support the extension and growth of vendor management and vendor readiness activities to cover full product lifecycle from development to commercial-scale manufacturing.
- Manage the vendor auditing program covering all aspects of Project QA to ensure compliance with ISO 13485, FDA QSR, and MDR 2017/745 and Invox QAAs.
- Lead or support vendor qualification, surveillance, or for cause audits, from agenda to reporting, approval of CAOA plan and tracking to close-out.
- Establish and manage vendor risk assessments and performance monitoring, to ensure continued compliance, reliability, and timeliness in both development and commercial production.
- Implement root cause analysis (RCA) and CAPA frameworks to drive vendor continuous improvement and risk mitigation.
- Lead external compliance with requirements for quality event handling.
- Support QA review of vendor project documents and records as necessary
(including protocols, reports, methods, validation and batch records).
Compliance, Quality Systems & Continuous Improvement
- Support the maintenance and effectiveness of company certifications (ISO 13485) by ensuring vendor-, SKU-, and project-related documentation and processes are compliant.
- Lead Continuous Improvement (CI) initiatives for the company’s vendor management processes, SKU validation and documentation, and project quality assurance (risk management and design control).
- Proactively identify gaps and propose enhancements. Develop, review, and implement Standard Operating Procedures (SOPs) in support of CI .
- Lead Continuous Improvement (CI) initiatives for the company’s vendor management processes, SKU validation and documentation, and project quality assurance (risk management and design control).
- Proactively identify gaps and propose enhancements. Develop, review, and implement Standard Operating Procedures (SOPs) in support of CI .
Line Management & Leadership
- Provide mentorship and direct management to the Project Quality Engineers, ensuring their professional development and performance.
- Allocate workload and set priorities for Project Quality Engineer activities within the team.
- Foster a culture of quality, collaboration, compliance and continuous improvement within the company.
- Allocate workload and set priorities for Project Quality Engineer activities within the team.
- Foster a culture of quality, collaboration, compliance and continuous improvement within the company.
Skills, Knowledge and Expertise
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, Quality Assurance, or a related field.
- 10+ years of experience in quality assurance, quality engineer or related roles within the pharmaceutical or medical device industries.
- Strong knowledge of ISO 13485, EU MDR (2017/745), and US FDA regulations for medical devices and pharmaceutical manufacturing.
- Lead auditor in ISO13485, 9001 or GMP fields.
- Experience with SKU validation, FAT/SAT, IQ/OQ/PQ, MSA, and GR&R methodologies.
- Demonstrated ability to perform risk assessments and drive continuous improvement.
- Strong leadership and people management skills, with prior experience managing or mentoring team members preferred.
- Excellent problem-solving, analytical, and communication skills, with the ability to collaborate effectively with cross-functional teams and external vendors.
- Willingness to travel globally as required for vendor audits, project compliance and SKU validation activities.
- 10+ years of experience in quality assurance, quality engineer or related roles within the pharmaceutical or medical device industries.
- Strong knowledge of ISO 13485, EU MDR (2017/745), and US FDA regulations for medical devices and pharmaceutical manufacturing.
- Lead auditor in ISO13485, 9001 or GMP fields.
- Experience with SKU validation, FAT/SAT, IQ/OQ/PQ, MSA, and GR&R methodologies.
- Demonstrated ability to perform risk assessments and drive continuous improvement.
- Strong leadership and people management skills, with prior experience managing or mentoring team members preferred.
- Excellent problem-solving, analytical, and communication skills, with the ability to collaborate effectively with cross-functional teams and external vendors.
- Willingness to travel globally as required for vendor audits, project compliance and SKU validation activities.
Why work at invoX?
We get things done, we keep things simple and we are driven by the science. We are ambitious so we work hard to create an environment where we can take smart risks. We want to be innovative so encourage debate and collaboration to challenge the usual way of doing things. We love our celebrations and socialising, which make invoX a fun and diverse place to work. And most of all, everyone has the opportunity to make a difference.
