Senior Quality Engineer: Lead Quality Systems & Compliance

Nova Biomedical; Norwood (MA); Hybrid; USD 110,000 - 130,000; Full time

Benefits offered by this job

Flexible Medical, Dental, & Vision Coverage

401(k) company match

Bonus Program

Generous PTO and paid holidays

Tuition Reimbursement

Company subsidized cafeteria

Hybrid work arrangements

Job summary

Nova Biomedical, located in Norwood, MA, seeks a Senior Quality Engineer responsible for ensuring comprehensive quality practices across design transfer and production. This role requires leading quality initiatives, supporting equipment qualification, and resolving issues with R&D and Manufacturing Engineering.

The ideal candidate will have a Bachelor's degree in Engineering, 7+ years in a medical device environment, and strong knowledge of regulations such as ISO 9001 and ISO 13485. The position offers a hybrid work schedule and competitive benefits.

Qualifications

• 7+ years of experience as a Quality Engineer in a medical device/IVD company.
• Ability to interpret regulations and apply them appropriately.
• Experience in an FDA regulated environment.

Responsibilities

• Oversee and improve Nova Biomedical’s Quality Systems.
• Develop and communicate plans to resolve quality issues.
• Participate in external audits and interact with auditors.

Skills

Quality Systems Management

Regulations Knowledge (ISO 9001, ISO 13485)

Medical Device Experience

Excellent Communication Skills

Detail-oriented

Education

Bachelor’s degree in Engineering or Technical Sciences

Tools

MS Excel

Statistical Software (e.g. Minitab)

Master Control

Job description

Nova Biomedical, located in Norwood, MA, seeks a Senior Quality Engineer responsible for ensuring comprehensive quality practices across design transfer and production. This role requires leading quality initiatives, supporting equipment qualification, and resolving issues with R&D and Manufacturing Engineering.

The ideal candidate will have a Bachelor's degree in Engineering, 7+ years in a medical device environment, and strong knowledge of regulations such as ISO 9001 and ISO 13485. The position offers a hybrid work schedule and competitive benefits.