Senior Quality Engineer - Hybrid, Lead Quality Initiatives

Nova Biomedical; Norwood (MA); Hybride; USD 120 000 - 160 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k) match

Paid time off

Paid holidays

Hybrid work

Employee events

On-site lunch

Cafeteria subsidies

Résumé du poste

Nova Biomedical seeks a Senior Quality Engineer to provide quality engineering support across design transfer, inspection, production, and data monitoring. You will lead quality initiatives, support qualification activities, and ensure compliance with procedures.

You will collaborate with R&D and Manufacturing Engineering, resolve quality issues, strengthen Quality Systems, and drive continuous improvement. This role requires interaction with site leadership to influence quality and compliance.

Qualifications

• Bachelor's degree or higher in Engineering, Science, or related technical field.
• 7+ years of Medical Device or IVD Quality Engineering experience, or 4+ years in a Senior Quality Engineering role within FDA-regulated environment.
• Strong knowledge of ISO 9001, ISO 13485, ISO 14971, IVDR, and FDA requirements.
• Experience in FDA-regulated manufacturing environment.
• Excellent communication, organization, and multitasking abilities.
• Proficient with Microsoft Word and Excel; Microsoft Access is beneficial.
• Experience with Minitab for statistical analysis.

Responsabilités

• Oversee Quality Systems management and improvement.
• Develop plans to resolve quality issues and support process changes.
• Communicate quality risks and solutions to leadership.
• Mentor Quality Engineers.
• Review ECOs and Manufacturing Variances (MVs).
• Design and validate queries and reports using CAPA data.
• Lead Product Line Quality Committees (PLQCs).
• Develop and maintain Quality Control Plans and PFMEAs for new products.
• Analyze quality data and generate reports.
• Participate in external audits and respond to auditors.
• Ensure validation activities meet applicable requirements.

Connaissances

Quality planning

Analytical thinking

Cross-functional collaboration

Problem solving

Attention to detail

Communication skills

MS Word & Excel

Minitab

Formation

Bachelor's degree in Engineering/Science

Outils

MasterControl

Power BI

Microsoft Access

Description du poste

Nova Biomedical seeks a Senior Quality Engineer to provide quality engineering support across design transfer, inspection, production, and data monitoring. You will lead quality initiatives, support qualification activities, and ensure compliance with procedures.

You will collaborate with R&D and Manufacturing Engineering, resolve quality issues, strengthen Quality Systems, and drive continuous improvement. This role requires interaction with site leadership to influence quality and compliance.