MB&A
Quality Engineer (Consultant/1099) – Project Management Focus
MB&A, Poland, New York, United States
Quality Engineer (Consultant/1099) – Project Management Focus
Industry:
Medical Device / Orthopaedics / Life Sciences About the Role: MB&A is expanding its network of high-impact consultants to support strategic quality and project leadership initiatives for leading med tech and life sciences companies. We are seeking experienced
Quality Engineers with strong project management acumen
to join our consulting team on a 1099 basis. Ideal candidates will bring a mix of hands-on quality engineering expertise, cross-functional leadership, and deep familiarity with regulatory frameworks such as FDA 21 CFR, ISO 13485, and EU MDR. Key Responsibilities: Lead and support quality engineering activities across the full product lifecycle—from development to post-market surveillance. Drive the implementation, validation, and optimization of electronic Quality Management Systems (eQMS). Develop and harmonise procedures, SOPs, and work instructions in alignment with FDA, ISO, and EU MDR standards. Perform risk assessments, root cause analysis, and CAPA investigations using structured methodologies. Oversee and coordinate regulatory and quality deliverables for manufacturing transfers, product design, and supplier transitions. Provide audit readiness and support during FDA, ISO, BSI, and other regulatory body inspections. Collaborate with cross-functional teams (Regulatory, R&D, Supply Chain, Operations) to ensure quality plans are integrated with broader project goals. Design and deploy project dashboards, quality metrics, and executive-level reporting. Mentor and train internal teams on quality processes, tools, and best practices. Requirements
Qualifications: Bachelor’s or Master’s Degree
in Mechanical Engineering, Biomedical Engineering, Engineering Science, or related discipline. Minimum
10 years
of quality engineering experience within the medical device or biotech industry. Proven
project management experience
in quality system implementation, regulatory compliance projects, and process harmonisation. Experience with medical device product development, design transfer, and technical documentation. Familiarity with standards and regulations including
FDA 21 CFR Part 820/QSMR
,
Part 803
,
Part 806
,
ISO 13485
,
ISO 14971
,
EU MDR
;
AATB preferred
. Proficiency in QMS platforms and
other ERP/QMS software
. Experience leading global process harmonisation initiatives (e.g., CAPA, NCE, complaints, inspections). CQE certification required Certifications (Highly Desirable): Project Management Professional (PMP)
– required for senior roles Medical Device Reporting (MDR) and Complaint Handling Training CQA, RAPS or equivalent Quality/Regulatory certifications Regulatory Acumen Clear Technical Communication Stakeholder Engagement & Change Management
#J-18808-Ljbffr
Industry:
Medical Device / Orthopaedics / Life Sciences About the Role: MB&A is expanding its network of high-impact consultants to support strategic quality and project leadership initiatives for leading med tech and life sciences companies. We are seeking experienced
Quality Engineers with strong project management acumen
to join our consulting team on a 1099 basis. Ideal candidates will bring a mix of hands-on quality engineering expertise, cross-functional leadership, and deep familiarity with regulatory frameworks such as FDA 21 CFR, ISO 13485, and EU MDR. Key Responsibilities: Lead and support quality engineering activities across the full product lifecycle—from development to post-market surveillance. Drive the implementation, validation, and optimization of electronic Quality Management Systems (eQMS). Develop and harmonise procedures, SOPs, and work instructions in alignment with FDA, ISO, and EU MDR standards. Perform risk assessments, root cause analysis, and CAPA investigations using structured methodologies. Oversee and coordinate regulatory and quality deliverables for manufacturing transfers, product design, and supplier transitions. Provide audit readiness and support during FDA, ISO, BSI, and other regulatory body inspections. Collaborate with cross-functional teams (Regulatory, R&D, Supply Chain, Operations) to ensure quality plans are integrated with broader project goals. Design and deploy project dashboards, quality metrics, and executive-level reporting. Mentor and train internal teams on quality processes, tools, and best practices. Requirements
Qualifications: Bachelor’s or Master’s Degree
in Mechanical Engineering, Biomedical Engineering, Engineering Science, or related discipline. Minimum
10 years
of quality engineering experience within the medical device or biotech industry. Proven
project management experience
in quality system implementation, regulatory compliance projects, and process harmonisation. Experience with medical device product development, design transfer, and technical documentation. Familiarity with standards and regulations including
FDA 21 CFR Part 820/QSMR
,
Part 803
,
Part 806
,
ISO 13485
,
ISO 14971
,
EU MDR
;
AATB preferred
. Proficiency in QMS platforms and
other ERP/QMS software
. Experience leading global process harmonisation initiatives (e.g., CAPA, NCE, complaints, inspections). CQE certification required Certifications (Highly Desirable): Project Management Professional (PMP)
– required for senior roles Medical Device Reporting (MDR) and Complaint Handling Training CQA, RAPS or equivalent Quality/Regulatory certifications Regulatory Acumen Clear Technical Communication Stakeholder Engagement & Change Management
#J-18808-Ljbffr