Senior Quality Operations Lead - GMP/ISO, CAPA & Release

Terumo Aortic; Town of Florida (NY); On-site; USD 90,000 - 120,000; Full time

Job summary

Terumo Aortic is looking for a Quality Assurance Manager in Florida, NY. The successful candidate will lead the quality operation staff, ensuring compliance with ISO standards and managing nonconforming events. The role requires strong leadership with 8+ years in QA or manufacturing within a regulated environment.

Qualifications include a bachelor's degree in Engineering or Quality Engineering, alongside significant experience in medical device processes. Applicants should exhibit excellent communication skills and an ability to influence others while promoting a quality-driven culture.

Qualifications

• 8+ years of related experience in a regulated Quality Assurance environment.
• Understanding of medical device design and process controls per FDA QSRs and ISO 13485.
• Experience handling nonconforming events.

Responsibilities

• Manage Production Quality staff and oversee QA processes.
• Identify and monitor nonconforming events.
• Perform product failure investigations and implement corrective actions.
• Interact with cross-functional teams to resolve quality issues.
• Support CAPA system and address compliance issues.

Skills

Communication skills

Organizational skills

Leadership ability

Influencing others

Ability to multitask

Education

Bachelor's degree in Engineering or Quality Engineering

Job description

Terumo Aortic is looking for a Quality Assurance Manager in Florida, NY. The successful candidate will lead the quality operation staff, ensuring compliance with ISO standards and managing nonconforming events. The role requires strong leadership with 8+ years in QA or manufacturing within a regulated environment.

Qualifications include a bachelor's degree in Engineering or Quality Engineering, alongside significant experience in medical device processes. Applicants should exhibit excellent communication skills and an ability to influence others while promoting a quality-driven culture.