Senior Quality Engineer — Hybrid, Lead Quality Systems

NOVA Biomedical GmbH; Norwood (MA); Ibrido; USD 110.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

401k company match

Bonus Program

Generous PTO and paid holidays

Professional development opportunities

Subsidized cafeteria in Waltham, MA

Descrizione del lavoro

NOVA Biomedical GmbH in Norwood, Massachusetts is seeking a Senior Quality Engineer to enhance quality practices across design transfer, production, and compliance. This role involves managing quality initiatives and collaborating with multiple teams to ensure adherence to regulatory standards.

The ideal candidate will have over 7 years of experience in the medical device industry, demonstrate strong communication skills, and a solid understanding of FDA regulations. The position offers a hybrid work model and competitive compensation.

Competenze

• 7+ years of experience as a Quality Engineer in a medical device or IVD manufacturing context.
• Ability to interpret and apply relevant standards (ISO 9001, ISO 13485, ISO 14971).
• Excellent oral and written communication skills.

Mansioni

• Ensure compliance with quality practices in design transfer, inspection, and production.
• Manage Nova Biomedical’s Quality Systems, including audits and change management.
• Mentor and guide quality engineers in best practices.

Conoscenze

Medical Device/IVD Experience

FDA Regulations Knowledge

Communication Skills

Detail-oriented

Problem-solving Skills

Formazione

Bachelor's degree or higher in Engineering or technical sciences

Strumenti

MS Word

MS Excel

Statistical Software (Minitab)

Master Control

Power BI

Descrizione del lavoro

NOVA Biomedical GmbH in Norwood, Massachusetts is seeking a Senior Quality Engineer to enhance quality practices across design transfer, production, and compliance. This role involves managing quality initiatives and collaborating with multiple teams to ensure adherence to regulatory standards.

The ideal candidate will have over 7 years of experience in the medical device industry, demonstrate strong communication skills, and a solid understanding of FDA regulations. The position offers a hybrid work model and competitive compensation.